FDA.reportPublic FDA data

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
IngredientStrength
SALICYLIC ACID20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
346298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2619cc3b-5246-4519-94c4-07e0338b273cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64127-195-01GM COLLIN PURACNE1 in 1 CARTONGEL14
64127-195-01GM COLLIN PURACNE50 mL in 1 TUBEGEL504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64127-195GM COLLIN PURACNE (SALICYLIC ACID) GEL [LABORATOIRES DERMO-COSMETIK INC.]3Current NDC, Legacy NDC, 2 package rows20231004_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 31 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Beauty Medicated Apricot Cleanser Acne MedicationSALICYLIC ACIDWALMART INC.2b94e93f-cdce-919a-e063-6294a90adc302025-01-14WarningsExact identifier
application number: M006
SUNDAY RILEY U.F.O Acne Treatment Face OilSALICYLIC ACIDSunday Riley Modern Skincare, LLC90bd3b3b-3b42-4369-8b9a-a81dd8b6a1e52025-01-14WarningsExact identifier
application number: M006
AcNe solutionSALICYLIC ACIDNoon Aesthetics M.R. Ltd04c048c6-4035-4599-a29e-ff3c7f58e58a2025-01-13WarningsExact identifier
application number: M006
SLMD Salicylic Acid Body WashSALICYLIC ACIDOwen Biosciences Inc.86b95f37-cef1-424b-87e0-9ed7eca5d2592025-01-13WarningsExact identifier
application number: M006
SLMD Silver Sulfur Acne CreamSULFUROwen Biosciences Inc.4735a6d6-bf87-404d-a46d-7f29fcff94092025-01-13WarningsExact identifier
application number: M006
Double FightSALICYLIC ACID AND BENZOYL PEROXIDENoon Aesthetics M.R. Ltd1fb83be2-6140-45e8-a95f-188f147a038d2025-01-13WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURKate Somerville Skincare, LLC713093d9-29c3-44c9-b90f-ee7448c5063e2025-01-12WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDKATE SOMERVILLE SKINCARE, LLC4378b359-8eb9-4095-a106-45e1107580992025-01-12WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURKate Somerville Skincare, LLCbebe3042-b80c-41ca-b8df-48093573c0822025-01-12WarningsExact identifier
application number: M006
Exuviance Daily Acne PeelSALICYLIC ACIDNeoStrata Company Inc.e9f7da8a-c595-4500-89f1-ec8a2a72ef592025-01-10WarningsExact identifier
application number: M006
Drs. ACNE CLEARSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACYd6faa57c-d081-b57c-e053-2a95a90a79262025-01-09WarningsExact identifier
application number: M006
innisfree Gentle Retinol Salicylic Acne SerumSALICYLIC ACID GELInnisfree Corporation2b38b6f2-0de5-581b-e063-6394a90acd552025-01-08WarningsExact identifier
application number: M006
Nutricentials Here You Glow Exfoliating TonerSALICYLIC ACIDNSE Products, Inc.ecf6c01b-50e5-4cfd-8ac3-0027cdc33f902025-01-07WarningsExact identifier
application number: M006
Zitlox Salicylic AcneSALICYLIC ACIDASA Universal Inc. dba: SONAGE4b833d7a-f957-4e65-be5b-1771493149582025-01-06WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin CleanserGLO SKIN BEAUTY CLEAR SKIN CLEANSERHayden Caleel LLC07f51d83-e956-442c-9afa-aa987a66ae9e2025-01-05WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin Spot TreatmentGLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENTHayden Caleel LLC9f33ffc7-2727-491e-a361-7f130c81d1b12025-01-05WarningsExact identifier
application number: M006
Acne Defense Face WashSALICYLIC ACIDPacifica Beauty, LLCf43590c7-84c0-6eb8-e053-2a95a90a01a72025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body ScrubSALICYLIC ACIDPacifica Beauty, LLCf44a4fc5-3358-5966-e053-2995a90add562025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body WashSALICYLIC ACIDPacifica Beauty, LLCf45b4c77-45a3-f480-e053-2995a90a36be2025-01-03WarningsExact identifier
application number: M006
Acne Warrior Clearing AstringentSALICYLIC ACIDPacifica Beauty, LLCf44bcd96-dbf8-5718-e053-2a95a90adc342025-01-03WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN2619cc3b-5246-4519-94c4-07e0338b273c4
346298salicylic acid 0.02 MG/MG Topical GelSCD2619cc3b-5246-4519-94c4-07e0338b273c4
346298salicylic acid 2 % Topical GelSY2619cc3b-5246-4519-94c4-07e0338b273c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64127-195-01641270195011 TUBE in 1 CARTON (64127-195-01) / 50 mL in 1 TUBE1 tube2018-11-260000-00-00NoNoCurrent