Is Benzocaine safe for babies and kids?
Severe risk for kidsCONTRAINDICATED in infants under 2 years. FDA black box warning due to life-threatening methemoglobinemia risk.
What is benzocaine?
Benzocaine is a local anesthetic, ester-type anesthetic, OTC topical analgesic.
The IUPAC name is ethyl 4-aminobenzoate.
Also known as: ethyl 4-aminobenzoate, ethyl p-aminobenzoate, Americaine, Orajel (active ingredient).
- IUPAC name
- ethyl 4-aminobenzoate
- CAS number
- 94-09-7
- Molecular formula
- C9H11NO2
- Molecular weight
- 165.19 g/mol
- SMILES
- CCOC(=O)C1=CC=C(N)C=C1
- PubChem CID
- 2337
Risk for babies
Severe riskCONTRAINDICATED in infants under 2 years. FDA black box warning due to life-threatening methemoglobinemia risk.
Infants are at highest risk for benzocaine-induced methemoglobinemia due to: (1) higher proportion of fetal hemoglobin which is more susceptible to oxidation, (2) lower levels of NADH-cytochrome b5 reductase (methemoglobin reductase), (3) higher dose-to-weight ratio from oral mucosal application. FDA required label changes in 2018 contraindicating use in children under 2. Teething gels containing benzocaine have caused multiple infant deaths.
Risk for pregnant and nursing people
Moderate riskLimited pregnancy-specific data. Topical use at recommended doses generally considered low risk, but methemoglobinemia in the mother could compromise fetal oxygenation.
Benzocaine is FDA Pregnancy Category C (animal studies have shown adverse effects; no adequate human studies). Topical absorption is limited, but maternal methemoglobinemia would reduce oxygen delivery to the fetus. Use during pregnancy should be limited to situations where benefit outweighs risk.
Regulatory consensus
4 regulatory and scientific bodies have classified Benzocaine. The classifications differ — that's the data.
| Agency | Year | Classification | Notes |
|---|---|---|---|
| FDA | 2018 | OTC monograph drug; contraindicated in children under 2 years | FDA Drug Safety Communication (2018): required label changes to warn against use in children younger than 2 years. Multiple safety communications since 2006. |
| EU Cosmetics Regulation | — | Permitted in cosmetics at max 0.5% | EU Cosmetics Regulation (EC) No 1223/2009 — permitted as topical anesthetic in cosmetic products at limited concentration |
| MHRA (UK) | — | Restricted OTC teething use | UK MHRA restricted OTC availability of benzocaine teething products following FDA safety communications |
| Health Canada | — | Restricted OTC teething use | Health Canada issued safety review and restricted benzocaine use in children under 2 |
Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.
Where kids encounter benzocaine
-
Oral Pain Relief
— Orajel, Anbesol, Hurricaine gel, dental topical anesthetics
Primary OTC use — oral mucosal analgesia for toothache, canker sores, denture pain
-
Teething Products
— Baby Orajel (discontinued/reformulated), teething gels
FDA contraindicated for children under 2 years since 2018
-
Sunburn Relief
— Dermoplast, Solarcaine, sunburn relief sprays
Topical spray formulations for minor burn pain relief
-
Throat Products
— Cepacol lozenges, sore throat sprays, cough drops
Used as local anesthetic in throat lozenges and sprays
-
Personal Products
— desensitizing condoms, premature ejaculation delay products
Used at low concentrations (5-7.5%) as topical desensitizer
Safer alternatives
Lower-risk approaches that achieve a similar outcome to Benzocaine:
- Lidocaine (amide-type, lower methemoglobinemia risk)
- Chilled teething rings (non-pharmacologic, for infants)
- Ibuprofen or acetaminophen (systemic analgesics for teething pain in age-appropriate children)
Frequently asked questions
Is benzocaine safe for kids?
CONTRAINDICATED in infants under 2 years. FDA black box warning due to life-threatening methemoglobinemia risk.
What products contain benzocaine?
Benzocaine appears in: Orajel (oral pain relief); Anbesol (oral pain relief); Baby Orajel (discontinued/reformulated) (teething products); teething gels (teething products); Dermoplast (sunburn relief).
What should I do if my child is exposed to benzocaine?
DO NOT USE in infants. Use alternative teething pain relief (chilled teething rings, gentle gum massage). Seek emergency care immediately if exposure occurs.
Why do regulators disagree about benzocaine?
Benzocaine has been classified by 4 agencies including FDA, EU Cosmetics Regulation, MHRA (UK), Health Canada, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.
See Benzocaine in the baby app
Look up products containing benzocaine, compare to alternatives, and explore the full data record.
Open in baby View raw API dataReference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →