Home NDC 71888-101 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.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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 table Ingredient Strength BENZOCAINE 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 452688 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table 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# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71888-101 BENZOCAINE GEL [BELLUS MEDICAL, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241120_60cafbaf-8ec6-46a5-e053-2a91aa0af11f.zip
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.
Matched openFDA labels page 60 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF VALU MERCHANDISERS, CO 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff 2025-11-24 Warnings Exact identifier application number: M017 Menthol MAXIMUM STRENGTH MEDICATED FOOT POWDER VALU MERCHANDISERS, CO 89a5c4bb-442f-d3f0-e053-2a95a90a51bd 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d113dec-8832-d984-e063-6394a90ae7b3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d12f03f-dd8b-0be5-e063-6294a90a43db 2025-11-24 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL Clarion Brands LLC 445db02a-c8e8-6ebb-e063-6294a90a4301 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d129641-eaea-c3ee-e063-6394a90aa58f 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d1059cc-1b0b-4e7b-e063-6294a90a56ea 2025-11-24 Warnings Exact identifier application number: M017 GuruNanda Pain Relief MENTHOL AND CAMPHOR GURUNANDA, LLC 3ca78342-cc6d-5f6b-e063-6294a90a3f1c 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d118256-90ee-28ef-e063-6394a90a21e8 2025-11-24 Warnings Exact identifier application number: M017 health beyond HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af 2025-11-23 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 3 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 4429fea8-46f8-8f7f-e063-6394a90a34b4 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 2 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442a926b-d7c1-4e35-e063-6394a90ad948 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442aae32-4ac6-5dd6-e063-6294a90aad02 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1-3 Step 21MG NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442ae0fa-a1ed-7901-e063-6294a90ab717 2025-11-22 Warnings Exact identifier application number: M017 IceQuake Lidocaine Analgesic LIDOCAINE HYDROCHLORIDE Dextrum Laboratories, Inc 441daa6f-f273-ac09-e063-6394a90a252c 2025-11-21 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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