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 |
|---|---|---|---|---|---|---|
| Nufabrx Medicine Infused Socks | CAPSAICIN | Nufabrx LLC | 00d7d5bf-ee03-e73d-e063-6394a90a5d94 | 2025-10-15 | Warnings | M017 |
| Nufabrx Medicine Infused Elbow Sleeve | CAPSAICIN | Nufabrx LLC | 27ef3ef0-2f98-6672-e063-6294a90aeca4 | 2025-10-15 | Warnings | M017 |
| Nufabrx Medicine Infused Wrist Sleeve | CAPSAICIN | Nufabrx LLC | 22572cf9-fc0c-d327-e063-6394a90a2186 | 2025-10-15 | Warnings | M017 |
| Antibacterial Lidocaine Wound Gel | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | WALGREENS | eff77965-dc7f-49af-e053-2995a90a1a97 | 2025-10-14 | Warnings | M017 |
| Pleasure Balm Kama Sutra | BENZOCAINE | Cosmetic Enterprises Ltd | f370e3c4-65ca-4f3c-a5aa-70e198e681a2 | 2025-10-14 | Warnings | M017 |
| Vanicream HC Anti-Itch | HYDROCORTISONE | Pharmaceutical Specialties, Inc. | 28b06507-27a5-2cb1-e054-00144ff8d46c | 2025-10-14 | Warnings | M017 |
| Trilogel | LIDOCAINE HYDROCHLORIDE | Trifluent Pharma LLC | 22af7d63-6a56-4a38-a95b-0f88410b23cb | 2025-10-14 | Warnings | M017 |
| PROINNATE Numbing Cream | MENTHOL | Guangzhou Haishi Biological Technology Co., Ltd. | 40c63645-8ed3-82b3-e063-6294a90a5267 | 2025-10-13 | Warnings | M017 |
| Cramergesic | MENTHOL, METHYL SALICYLATE | The Hygenic Company, LLC | d0ffde7a-6942-74fc-e053-2a95a90a484a | 2025-10-13 | Warnings | M017 |
| Tricylate | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Trifluent Pharma LLC | 4869b63a-e01e-4a79-a493-7a1b4d3e914b | 2025-10-13 | Warnings | M017 |
| Doloflex Pain Relief | MENTHOL, METHYL SALICYLATE | United Health & Beauty Corp | 32a830cc-04d3-102e-e063-6294a90a1cad | 2025-10-12 | Warnings | M017 |
| Lidocaine Pain Relieving Gel-Patch | LIDOCAINE | Nanjing Anxing Medical Technology Co., Ltd. | 40c9b132-57ce-865e-e063-6394a90a2080 | 2025-10-10 | Warnings | M017 |
| Kinesys | ZINC OXIDE | Wilc Healthcare Inc | a32b44c3-eda0-48ea-95fc-250a2c2396ca | 2025-10-10 | Warnings | M017 |
| Te-Fu Recovery Massage | MENTHOL, METHYL SALICYLATE | Wasatch Product Development | 7bc2989f-dfb6-e8af-e053-2991aa0a0bf2 | 2025-10-10 | Warnings | M017 |
| Anti-itch | HYDROCORTISONE | Medline Industries, LP | b0947381-c0db-4253-ab40-3d45603ae65d | 2025-10-09 | Warnings | M017 |
| Kalaya Pain Relief | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | e2452c4b-2548-497f-828b-5d960402522a | 2025-10-08 | Warnings | M017 |
| Kalaya Pain Relief 6X with Arnica | PAIN RELIEF CREAM | Avaria Health & Beauty Corp | 60198d2e-4de3-3fa0-e053-2a91aa0afaf7 | 2025-10-08 | Warnings | M017 |
| KALAYA PAIN RELIEF 6X WITH ARNICA - Pain Relief | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 9b9b7cad-a5e2-4445-856b-4aa439d77a80 | 2025-10-08 | Warnings | M017 |
| KALAYA FOAMING PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | d5021e6d-f29f-446b-874c-bdcabd9cf4f6 | 2025-10-08 | Warnings | M017 |
| KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | e0c9f22a-165a-4558-ba3c-8592f1bd0016 | 2025-10-08 | 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 |