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 34 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHBentley Laboratories, LLCeb7fa2b5-3bdb-436c-8576-1eea29b8d1ff2024-12-27WarningsExact identifier
application number: M006
Acne Control Superclean Body Wash AHA BHA FormulaSALICYLIC ACIDBentley Laboratories, LLC16fd3343-d044-4f6b-af1a-30bc32ce20412024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5726d12c-708c-46e6-a584-9e5c7a544fc82024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Clarifying Exfoliating CleanserSALICYLIC ACIDL'Oreal USA Products Inca0cc4ae7-c266-4321-92e6-a46d560a74b22024-12-27WarningsExact identifier
application number: M006
BRODA AcneSALICYLIC ACIDBentley Laboratories, LLCb7e1f105-8998-46a5-b1ae-85d21790b8162024-12-27WarningsExact identifier
application number: M006
Monat Be Clarified Acne-Clearing MoisturizerSALICYLIC ACIDCosmax Usa, Corporation2984d615-7ed1-46c3-e063-6294a90a1f8a2024-12-26WarningsExact identifier
application number: M006
Nativae Milia Acne SerumSALICYLIC ACIDCDE BRANDS LLCe04cf0a2-bda7-4e5b-9771-769995cf69252024-12-26WarningsExact identifier
application number: M006
Milani Erase Base Blemish Control PrimerSALICYLIC ACIDCosmax Usa, Corporation1b1f1948-2ad9-48d2-9871-6830b2442f432024-12-26WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cleansing PadsSALICYLIC ACID 0.5%The Mentholatum Company2a36b6c5-f518-66f0-e063-6394a90acd402024-12-26WarningsExact identifier
application number: M006
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a385fac-399b-c111-e063-6394a90aefc32024-12-26WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a398c8d-09e6-513b-e063-6294a90ad8572024-12-26WarningsExact identifier
application number: M006
DEEP ACNESULFURDermalogica, LLC.d4e9d230-2ee4-4cc7-a7c9-a7dde50b6f402024-12-26WarningsExact identifier
application number: M006
SUNDAY RILEY SATURN SULFUR ACNE SPOT TREATMENT MASKSULFURSunday Riley Modern Skincare, LLC35364a71-b011-42f5-9941-4a2f8440808b2024-12-26WarningsExact identifier
application number: M006
Breakout Clearing Foaming WashSALICYLIC ACIDDermalogicae55d212b-7687-47fd-86ec-f8709804dd042024-12-24WarningsExact identifier
application number: M006
BREAKOUT CLEARING BOOSTERSALICYLIC ACIDDermalogica, Inc.6a3bb679-8a03-4f0a-950e-5a40f2b5b70e2024-12-24WarningsExact identifier
application number: M006
AGE Bright Clearing SerumSALICYLIC ACIDDermalogica, Incd5291f67-3329-42c7-b9c2-9bae797ecb5b2024-12-24WarningsExact identifier
application number: M006
Maybelline Dream Pure BB Beauty BalmSALICYLIC ACIDL'Oreal USA Products Inc553bea8f-92cd-416c-8bc1-39e4ec9cfcb42024-12-23WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Blemish Clearing CleanserSALICYLIC ACIDLOreal USA Products Inc4e03b29c-6d1c-473c-91b9-291a0cb523fb2024-12-23WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial AstringentSALICYLIC ACID 2%Derma Care Research Labs, LLCd692e7e2-11c7-7b4a-e053-2a95a90ae17b2024-12-20WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial CleanserSALICYLIC ACID 2%Derma Care Research Labs, LLCd6e59f75-cd3d-3fc4-e053-2a95a90abf4c2024-12-20WarningsExact 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