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 138 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Joint and Muscle Pain MENTHOL Shaklee Corporation 3943824f-1f4f-4d6f-bd73-0b1be02162a5 2024-01-30 Warnings Exact identifier application number: M017 Mirakel Pain Relief Roll-On LIDOCAINE HCL Sanvio, Inc. 102f3618-13ad-37e3-e063-6294a90a8086 2024-01-30 Warnings Exact identifier application number: M017 Blistex Lip Medex PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL Blistex Inc. 8ad39005-9419-4f1a-a1ae-2f76d212455e 2024-01-26 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises ad5d6f04-15e6-4548-95c2-32271c186bc1 2024-01-25 Warnings Exact identifier application number: M017 MIND BODY MATRIX PAIN RELIEF MENTHOL Functional Energetic, Inc. 3667dd0d-942e-4101-ba98-cb013ae77cf5 2024-01-25 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS e6d27df5-118c-4c6d-86e8-7b4401a39c76 2024-01-23 Warnings Exact identifier application number: M017 Burn First Aid BURN FIRST AID Dynarex Corporation 826e08be-dffa-5a27-e053-2a91aa0a8701 2024-01-22 Warnings Exact identifier application number: M017 Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On MENTHOL TARGET CORPORATION 0f95fc55-8665-9e89-e063-6394a90a7891 2024-01-22 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief Plus Menthol LIDOCAINE, MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 77978069-a1b4-473e-83c9-8320e00eea89 2024-01-19 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE LEG CRAMPS CAMPHOR, MENTHOL KOBAYASHI Healthcare International, Inc. ba26635d-95d3-4d88-93cc-1fd4fd29fd79 2024-01-18 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health e95ebdac-9789-41c2-97da-2307e4538794 2024-01-18 Warnings Exact identifier application number: M017 Medi-First Hydrocortisone 1% HYDROCORTISONE ACETATE Unifirst First Aid Corporation bd216f5d-f304-7d8d-e053-2a95a90aa9ce 2024-01-17 Warnings Exact identifier application number: M017 Green Guard Hydrocortisone 1% HYDROCORTISONE Unifirst First Aid Corporation bd348e2a-57b1-3f17-e053-2a95a90a8bdc 2024-01-17 Warnings Exact identifier application number: M017 Pain Relief LIDOCAINE, MENTHOL HUMN Pharmaceuticals Inc 6c96f94a-e724-eab3-e053-2991aa0aab88 2024-01-17 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief LIDOCAINE Natural Essentials, Inc. 52e82e70-53b7-4ecb-be39-fe10c94cc444 2024-01-17 Warnings Exact identifier application number: M017 CVS Health XL Lidocaine Pain Relief LIDOCAINE NATURAL ESSENTIALS, INC. ec16da91-8244-402b-b8d8-84896094ac2c 2024-01-17 Warnings Exact identifier application number: M017 Anti-itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Target Corporation f444b0a6-2ed3-4236-8206-342150290675 2024-01-17 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone Anti-itch HYDROCORTISONE 1% Target Corporation 4ff39cb8-3a20-4fe7-9829-1e882a484668 2024-01-17 Warnings Exact identifier application number: M017 Salonpas Pain Relieving LIDOCAINE 4% FLEX LIDOCAINE Hisamitsu Pharmaceutical Co., Inc. 9507f727-c49f-4de4-9d64-b6d977d568ab 2024-01-17 Warnings Exact identifier application number: M017 Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. eca272cb-ac8f-982b-e053-2995a90aa8b2 2024-01-15 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