SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID

Product NDC
68634-057
11-digit product format
686340057
Labeler code
68634
Product ID
68634-057_74081f12-5dd9-4899-9c79-88e580b656ea
Type
HUMAN OTC DRUG
Nonproprietary name
salicylic acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
AMCOL Health & Beauty Solutions, Inc. DBA
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-05-01
Substance
SALICYLIC ACID
Active strength
20 g/2mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 g/2mL

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
103568Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4effc518-e869-4d10-aac1-82dc338e28b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68634-057-01SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID30 mL in 1 TUBELIQUID301
68634-057-01SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68634-057SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID (SALICYLIC ACID) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA]1Current NDC, Legacy NDC, 2 package rows20160617_4effc518-e869-4d10-aac1-82dc338e28b8.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACIDSALICYLIC ACIDAMCOL Health & Beauty Solutions, Inc. DBA4effc518-e869-4d10-aac1-82dc338e28b82016-06-11WarningsExact identifier
ndc (product): 68634-057

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103568salicylic acid 2 % Topical LotionPSN4effc518-e869-4d10-aac1-82dc338e28b81
103568salicylic acid 20 MG/ML Topical LotionSCD4effc518-e869-4d10-aac1-82dc338e28b81
103568salicylic acid 2 % Topical LotionSY4effc518-e869-4d10-aac1-82dc338e28b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68634-057-01686340057011 TUBE in 1 CARTON (68634-057-01) / 30 mL in 1 TUBE1 tube2014-05-010000-00-00NoNoCurrent