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 118 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE Patrin Pharma Inc. 91eedf9d-53b8-49d5-af59-25019606a0b2 2024-11-15 Warnings Exact identifier application number: M017 equaline anti itch maximum strength HYDROCORTISONE United Natural Foods, Inc. dba UNFI d1ac686e-62f2-4177-8abc-8c7ca578de1a 2024-11-15 Warnings Exact identifier application number: M017 Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc e688967e-799a-4fc8-a19a-f0012b90e76b 2024-11-15 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC a0d0e82b-03ff-4d43-9be0-0e414ee49970 2024-11-15 Warnings Exact identifier application number: M017 DG health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 40710bae-32bb-47fd-b3dd-31d2c98ee70f 2024-11-15 Warnings Exact identifier application number: M017 Meijer Ultra Strength Pain Relieving Topical Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Meijer Distribution, Inc 6319b019-8e17-4de1-b4e0-b402288a97d4 2024-11-15 Warnings Exact identifier application number: M017 Meijer Pain Relieving analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 9953be94-5768-448f-83de-f5e53a2972cc 2024-11-15 Warnings Exact identifier application number: M017 careone anti itch HYDROCORTISONE American Sales Company 5f7b1435-ebee-4093-847a-79e8d6641404 2024-11-15 Warnings Exact identifier application number: M017 Tiger Balm METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 51293a06-5922-4072-ae14-afaba9c1b58e 2024-11-14 Warnings Exact identifier application number: M017 Tylenol Precise Warming Pain Relieving LIDOCAINE Kenvue Brands LLC 0c60b607-ade9-68f2-e063-6394a90a4025 2024-11-13 Warnings Exact identifier application number: M017 Tylenol Precise Pain Relieving LIDOCAINE Kenvue Brands LLC fc1e0451-8c84-729e-e053-6394a90aaba0 2024-11-13 Warnings Exact identifier application number: M017 Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE Kenvue Brands LLC 23222e54-d793-4d79-980e-550e32a95742 2024-11-13 Warnings Exact identifier application number: M017 TopCare Pain Relieving Roll-On Topical Analgesic MENTHOL, UNSPECIFIED FORM Topco Associates LLC 48589893-ca67-471d-88bc-92014295ab9f 2024-11-13 Warnings Exact identifier application number: M017 Benadryl Extra Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Kenvue Brands LLC a1c1b878-d58f-41ff-b7a8-477f28c52667 2024-11-12 Warnings Exact identifier application number: M017 Real Time Pain Relief Maxx Plus Topical Analgesic MENTHOL Real Time Products Inc. fc509a55-594d-4d44-87db-33286e937581 2024-11-12 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Acme United Corporation f1f051ad-7e82-9d1a-e053-2a95a90ac7d3 2024-11-12 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE ALLIED TRADE LINK LLC 26bc238d-3bda-0c29-e063-6394a90a35fb 2024-11-12 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Acme United Corporation fabcaa3b-d189-bd29-e053-6294a90ae86b 2024-11-12 Warnings Exact identifier application number: M017 ActivICE MENTHOL Medline Industries, LP 8414aea2-52b5-4221-e053-2a91aa0a622e 2024-11-12 Warnings Exact identifier application number: M017 Pain Relieving Gel-Patch LIDOCAINE Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 26c7116f-c86d-8752-e063-6294a90ab73f 2024-11-12 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