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 42 of 54 · 1,079 matching rows.
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