Benzocaine
- Product NDC
- 71888-101
- 11-digit product format
- 718880101
- Labeler code
- 71888
- Product ID
- 71888-101_47fac2e8-50dd-cddf-e063-6394a90a9176
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bellus Medical, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-06-01
- Substance
- BENZOCAINE
- Active strength
- 200 mg/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 71888-101-02 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 71888-101-02 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 71888-101-02 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 71888-101-02 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 71888-101-02 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 71888-101-02 | 9bebd1f3094a… | 5416666fcb17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzocaine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 452688 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60cafbaf-8ec6-46a5-e053-2a91aa0af11f | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-10-27 | 20% Benzocaine Gel |
| 2023-10-27 | 20% Benzocaine Gel |
| 2020-01-31 | 20% Benzocaine Gel |
| 2020-01-31 | 20% Benzocaine Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71888-101-01 | Benzocaine | 4 mL in 1 PACKET | GEL | 4 | 4 | |
| 71888-101-02 | Benzocaine | 12 in 1 BOX | GEL | 12 | 4 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | ASCLEMED USA INC. | 68dc0231-3364-448b-bde9-f19fa122c765 | 2026-05-05 | Warnings | M017 |
| Lidocaine 4% Patch | LIDOCAINE 4% | SOLA Pharmaceuticals | c31957dd-edea-ce98-e053-2a95a90a9c2d | 2026-05-05 | Warnings | M017 |
| Biofreeze Triple Target Gel | CAMPHOR, CAPSAICIN, MENTHOL | Reckitt Benckiser LLC | 511852c8-7428-3234-e063-6394a90a5bc2 | 2026-05-05 | Warnings | M017 |
| 5Kind DMSO Pain Relieving | CAMPHOR (SYNTHETIC) | 5Kind Trading LTD | 62b55114-47f4-473a-8406-78238c3c1fa2 | 2026-05-04 | Warnings | M017 |
| Zinc Oxide with Menthol and White Petrolatum | MENTHOL, ZINC OXIDE, WHITE PETROLATUM | Aldermed Inc. | f993fc0a-bd80-4345-a948-65ac03f910e2 | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE PRODUCTS BURN RELIEF | LIDOCAINE HYDROCHLORIDE | EVERLIT GLOBAL INC. | d7ec5720-4d1f-4943-ae36-c7d6acbae7d7 | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE PRODUCTS BURN RELIEF | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 5371dae4-ea63-46cc-ac26-5418f359c63e | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a2cf1726-3dc9-4624-b898-ac91fb4cbdb2 | 2026-05-04 | Warnings | M017 |
| FIRSTAR BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 186343c5-2e71-49c4-8d64-5fb3131239fa | 2026-05-04 | Warnings | M017 |
| Feminine Anti Itch Cream | BENZOCAINE,RESORCINOL | TRIFECTA PHARMACEUTICALS USA LLC | 50c3acbf-b873-908a-e063-6294a90a66b7 | 2026-05-01 | Warnings | M017 |
| 24 7 Relief and Recovery Pain Relieving | MENTHOL, UNSPECIFIED FORM | Triplicare Inc | 53ca807b-3ec2-4b5e-aa5a-6dcb756bb423 | 2026-04-30 | Warnings | M017 |
| FIRST AID BURN | LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE | 4 Visions LLC | 50b1351d-72dd-e0c9-e063-6294a90ac743 | 2026-04-30 | Warnings | M017 |
| TheraCare Flexible Pain Relieving | LIDOCAINE | Veridian Healthcare | 4f108002-2cae-0671-e063-6294a90ab6cf | 2026-04-30 | Warnings | M017 |
| Pain Relief Gel Roll On | MENTHOL | Trifecta Pharmaceuticals USA | 50b1a420-d5cd-6d61-e063-6294a90a0451 | 2026-04-30 | Warnings | M017 |
| Dr. Numb | LIDOCAINE AND BENZETHONIUM CHLORIDE CREAM | Shinpharma Inc | d8cdccdb-775b-4970-a6ea-50b62df221d6 | 2026-04-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Padagis Israel Pharmaceuticals Ltd | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 2026-04-29 | Warnings | M017 |
| anti itch | HYDROCORTISONE | HyVee Inc | e1db3641-2e83-4fec-8394-98d0d876ce0d | 2026-04-29 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 50805eee-33b3-86bd-e063-6294a90a77d8 | 2026-04-28 | Warnings | M017 |
| FixMySkin Healing Balm Vanilla Flavor | HYDROCORTISONE | Lovely Skin, Inc. | 52f7a561-a0b5-4562-a588-d74fd874b83a | 2026-04-28 | Warnings | M017 |
| Blue Star Medicated | CAMPHOR | Focus Consumer Healthcare, LLC | 56df008e-a23b-4870-e054-00144ff8d46c | 2026-04-27 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 452688 | benzocaine 20 % Topical Gel | PSN | 60cafbaf-8ec6-46a5-e053-2a91aa0af11f | 4 |
| 452688 | benzocaine 0.2 MG/MG Topical Gel | SCD | 60cafbaf-8ec6-46a5-e053-2a91aa0af11f | 4 |
| 452688 | benzocaine 20 % Topical Gel | SY | 60cafbaf-8ec6-46a5-e053-2a91aa0af11f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71888-101-01 | 71888010101 | 4 mL in 1 PACKET | 4 ml | Historical | |||
| 71888-101-02 | 71888010102 | 12 PACKET in 1 BOX (71888-101-02) / 4 mL in 1 PACKET (71888-101-01) | 12 packet | 2017-06-01 | No | No | Current |