FDA.reportPublic FDA data

Salicylic Acid

Product NDC
42192-134
11-digit product format
421920134
Labeler code
42192
Product ID
42192-134_82acb5c3-24e6-4417-808c-74ad6003e76d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-19
Substance
SALICYLIC ACID
Active strength
60 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Salicylic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID60 mg/g

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
312893Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
996ad0d5-d635-4ed4-8263-d7f773260421Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-134-40Salicylic Acid40 g in 1 TUBEGEL407
42192-134-40Salicylic Acid1 in 1 CARTONGEL17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-134-40GM - Gram42192-1346800aa3e-fb0a-453f-9280-a299d1ad077012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID GEL [ACELLA PHARMACEUTICALS, LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALICYLIC ACID GEL [ACELLA PHARMACEUTICALS, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSALICYLIC ACID GEL [ACELLA PHARMACEUTICALS, LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSALICYLIC ACID GEL [ACELLA PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SALICYLIC ACID GEL [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSALICYLIC ACID GEL [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-134SALICYLIC ACID GEL [ACELLA PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 2 package rows20240112_996ad0d5-d635-4ed4-8263-d7f773260421.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
Salicylic AcidSALICYLIC ACIDAcella Pharmaceuticals, LLC996ad0d5-d635-4ed4-8263-d7f7732604212024-01-11Warnings, Adverse reactionsExact identifier
ndc (product): 42192-134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312893salicylic acid 6 % Topical GelPSN996ad0d5-d635-4ed4-8263-d7f7732604217
312893salicylic acid 0.06 MG/MG Topical GelSCD996ad0d5-d635-4ed4-8263-d7f7732604217
312893salicylic acid 6 % Topical GelSY996ad0d5-d635-4ed4-8263-d7f7732604217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-134-40421920134401 TUBE in 1 CARTON (42192-134-40) / 40 g in 1 TUBE1 tube2011-05-190000-00-00NoNoCurrent