Home NDC 64127-195 GM COLLIN PURACNE
Product NDC 64127-195
11-digit product format 641270195
Labeler code 64127
Product ID 64127-195_458b088b-5799-c4f7-e063-6294a90a1d84
Type HUMAN OTC DRUG
Nonproprietary name Salicylic Acid
Dosage form GEL
Route TOPICAL
Labeler Laboratoires Dermo-Cosmetik Inc.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-26
Substance SALICYLIC ACID
Active strength 20 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 GM COLLIN PURACNE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 346298 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64127-195-01 GM COLLIN PURACNE 1 in 1 CARTON GEL 1 4 64127-195-01 GM COLLIN PURACNE 50 mL in 1 TUBE GEL 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64127-195 GM COLLIN PURACNE (SALICYLIC ACID) GEL [LABORATOIRES DERMO-COSMETIK INC.] 3 Current NDC, Legacy NDC, 2 package rows 20231004_2619cc3b-5246-4519-94c4-07e0338b273c.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 45 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenix Gly-Sal 10-2 cleanser SALICYLIC ACID Topiderm, Inc. 00d1f8af-88de-4a14-80ec-5ee9fd38b191 2024-08-02 Warnings Exact identifier application number: M006 AL0076001 Alba Botanica Acnedote Deep Pore Wash SALICYLIC ACID The Hain Celestial Group, Inc. 6157c9c6-f252-5b49-e053-2991aa0ad8ed 2024-07-31 Warnings Exact identifier application number: M006 AL00761 Alba Botanica Acnedote Face and Body Scrub SALICYLIC ACID The Hain Celestial Group, Inc. c55efca6-5a5b-134b-e053-2a95a90a8245 2024-07-31 Warnings Exact identifier application number: M006 Gly-Sal 5-2 SALICYLIC ACID Topiderm, Inc. a75e4cee-678f-4e44-9e5e-bafae1c23f9b 2024-07-31 Warnings Exact identifier application number: M006 Face Reality Advanced Acne Med BENZOYL PEROXIDE Face Reality e1eb8496-0611-4dbc-befb-fb43ec164433 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 5% Advanced Acne Med BENZOYL PEROXIDE Face Reality 0e52972d-b4d9-43f8-8dbb-2eec0782e0f7 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 10% Advanced Acne Med BENZOYL PEROXIDE Face Reality a214ea15-6346-4729-ba84-fbc842faf92a 2024-07-26 Warnings Exact identifier application number: M006 Replenix Gly-Sal 2-2 SALICYLIC ACID Topiderm, Inc. 6c6bbedc-e2ee-46a0-8800-e356bdd262b0 2024-07-25 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Double Action Acne Serum SALICYLIC ACID L'Oreal USA Products Inc f9daadf9-a9d3-4f2d-af07-5f0b70f7803f 2024-07-17 Warnings Exact identifier application number: M006 BLEMISH DOTS - RETINOL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. c7164d75-75e7-494a-9595-028ecbf26276 2024-07-14 Warnings Exact identifier application number: M006 BLEMISH DOTS - CHARCOAL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. 286f642f-7359-41b9-9daf-e866a87fbefa 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 74c49388-3314-47e8-80b1-19c09e6ea1f9 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 873de079-8b8d-45cd-8c7c-4645818f5aaa 2024-07-14 Warnings Exact identifier application number: M006 Dr. Zenovia Clear Complexion SALICYLIC ACID Topiderm, Inc. 4ff9b26d-3cd9-4539-b389-edd2df24a466 2024-06-28 Warnings Exact identifier application number: M006 LEROSETT Botanical Acne Cleanser SALICYLIC ACID GUNILLA OF SWEDEN, INC. 8b31d155-c257-4452-9e22-0c69fa36173e 2024-06-27 Warnings Exact identifier application number: M006 SkinCeuticals Silymarin CF Acne Treatment Antioxidant SALICYLIC ACID Cosmetique Active Production fcc3c44b-3090-45b5-91e4-e591c92a08c8 2024-06-24 Warnings Exact identifier application number: M006 Peace Out Early Stage Acne Dot SALICYLIC ACID Peace Out LLC. 0632d458-d326-ade4-e063-6294a90af3ba 2024-06-20 Warnings Exact identifier application number: M006 Replenix BP Acne BENZOYL PEROXIDE Topiderm, Inc. f449e020-a4d8-4a1b-82eb-4dc59e99b8d4 2024-06-18 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. ecf22bd1-4fc3-4455-ae01-13f97f53dc34 2024-06-17 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Tan SALICYLIC ACID Fourstar Group USA, Inc. 1158f6c2-2b59-4ed3-8d28-73b6da885a5d 2024-06-17 Warnings Exact identifier application number: M006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64127-195-01 64127019501 1 TUBE in 1 CARTON (64127-195-01) / 50 mL in 1 TUBE 1 tube 2018-11-26 0000-00-00 No No Current