Home NDC 71888-103 Tetracaine
Product NDC 71888-103
11-digit product format 718880103
Labeler code 71888
Product ID 71888-103_47faba68-aab7-7eb8-e063-6294a90a3931
Type HUMAN OTC DRUG
Nonproprietary name Tetracaine
Dosage form GEL
Route TOPICAL
Labeler Bellus Medical, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-06-01
Substance TETRACAINE HYDROCHLORIDE
Active strength 20 mg/1000mL
Pharmacologic classes Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
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 71888-103-02 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 71888-103-02 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 71888-103-02 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 71888-103-02 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 71888-103-02 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 71888-103-02 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 Tetracaine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRACAINE HYDROCHLORIDE 20 mg/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5NF5D4OPCI Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71888-103-01 Tetracaine 4 mL in 1 PACKET GEL 4 4 71888-103-02 Tetracaine 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 71888-103 TETRACAINE GEL [BELLUS MEDICAL, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241120_60cabb5f-606b-7a74-e053-2a91aa0ac024.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 26 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Sabharwals LIDOCAINE 4% GEL PATCH Dr. Sabharwal's Wound Care 102399b6-5be9-ee5e-e063-6394a90a3198 2026-04-02 Warnings Exact identifier application number: M017 TATTOO NUMBX NUMBING PAIN RELIEVING LIDOCAINE HYDROCHLORIDE Scyberco Ltd ac8eac04-ed5b-4c8e-9f9b-54d160b74606 2026-04-02 Warnings Exact identifier application number: M017 FifthPulse Hydrocortisone HYDROCORTISONE WeCare Products LLC f1fcb045-4a15-431b-9617-67eae9f87fbd 2026-04-02 Warnings Exact identifier application number: M017 ANIXIKE Cream MENTHOL 5% CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 4e8510e6-c0c7-bf6b-e063-6294a90a3b00 2026-04-02 Warnings Exact identifier application number: M017 RAPID RELIEF 0.025% CAPSAICIN PAIN PATCH 83569 4ed549e8-0062-fb03-e063-6294a90aac65 2026-04-02 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL AND ZINC ACETATE CVS Pharmacy 7e921988-ec66-38dc-e053-2a91aa0a7346 2026-04-01 Warnings Exact identifier application number: M017 The Best Numbing Cream TBNC The Best Numbing Cream LLC 4ca3923b-f586-0aaf-e063-6294a90a16c1 2026-03-31 Warnings Exact identifier application number: M017 ChapStick Classic Medicated EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42798a6c-2d7e-80f6-e063-6294a90a105f 2026-03-31 Warnings Exact identifier application number: M017 Roll-On Pain Relief Liquid LIDOCAINE HCL HyVee Inc 4da6f6fb-b182-360f-e063-6294a90abdf3 2026-03-31 Warnings Exact identifier application number: M017 Hand Sanitizer ALCOHOL ProStat First Aid 4e54aecb-190f-3866-e063-6294a90a810a 2026-03-31 Warnings Exact identifier application number: M017 Burn Mist LIDOCAINE HYDROCHLORIDE Water-Jel Technologies c53ab9dd-351a-400b-b873-4f396e0af54d 2026-03-31 Warnings Exact identifier application number: M017 Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving LIDOCAINE HYDROCHLORIDE Sato Pharmaceutical Co., Ltd. f7faddb2-5153-4fdd-a5ef-778182cef460 2026-03-31 Warnings Exact identifier application number: M017 ZENOL COOL METHYL SALICYLATE, L-MENTHOL BA TRADE INC 4e5c45f4-88ce-3a13-e063-6394a90a2a09 2026-03-31 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 091451fb-e30a-0012-e063-6394a90a3ba8 2026-03-31 Warnings Exact identifier application number: M017 Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint MENTHOL Chattem, Inc. b16ba9c2-23bf-4fdf-b44b-7abb9fec1911 2026-03-31 Warnings Exact identifier application number: M017 DR.PABU NUMBING LIDOCAINE 5% NUMBING Jiangxi Yudexi Pharmaceutical Co., LTD 4e3a3c6c-4821-76ea-e063-6294a90a8f96 2026-03-30 Warnings Exact identifier application number: M017 Doctor Jiao Antifungal Cream MICONAZOLE NITRATE Jiangxi Haiwei Pharmaceutical Co., Ltd. 4e3b231e-0642-bf63-e063-6394a90a905b 2026-03-30 Warnings Exact identifier application number: M017 CVS Muscle Balm and Roll-On CAMPHOR, MENTHOL CVS Pharmacy 4e40025a-070a-508e-e063-6394a90af5d7 2026-03-30 Warnings Exact identifier application number: M017 REGENECARE HA LIDOCAINE HCL MPM Medical LLC c3eec066-38e8-4617-b34d-2f72ffb7a324 2026-03-30 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Matcha Honey CAMPHOR, MENTHOL The Mentholatum Company 4e03a721-73f3-b2f2-e063-6394a90a44e6 2026-03-27 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71888-103-01 71888010301 4 mL in 1 PACKET 4 ml Historical 71888-103-02 71888010302 12 PACKET in 1 BOX (71888-103-02) / 4 mL in 1 PACKET (71888-103-01) 12 packet 2017-06-01 No No Current