FDA.reportPublic FDA data

SALICYLIC ACID

Product NDC
42192-135
11-digit product format
421920135
Labeler code
42192
Product ID
42192-135_5036e92f-8304-0e9d-e063-6394a90ab3ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-10-10
Marketing end
2027-07-31
Substance
SALICYLIC ACID
Active strength
275 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SALICYLIC ACID

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID275 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
1095689Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
572171f7-832f-4710-b888-eef5638fc9d4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-135-10SALICYLIC ACID1 in 1 CARTONLIQUID15
42192-135-10SALICYLIC ACID10 mL in 1 BOTTLE, WITH APPLICATORLIQUID105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-135-10ML - Milliliter42192-13500667baa-6c8a-4c51-ba54-ec4caa65f50812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID LIQUID [ACELLA PHARMACEUTICALS, LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALICYLIC ACID LIQUID [ACELLA PHARMACEUTICALS, LLC]1
BUTYL ACETATEINACTIVE INGREDIENT464P5N1905SALICYLIC ACID LIQUID [ACELLA PHARMACEUTICALS, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SALICYLIC ACID LIQUID [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-135SALICYLIC ACID LIQUID [ACELLA PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240112_572171f7-832f-4710-b888-eef5638fc9d4.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, LLC572171f7-832f-4710-b888-eef5638fc9d42026-04-24Adverse reactionsExact identifier
ndc (product): 42192-135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095689salicylic acid 27.5 % Topical SolutionPSN572171f7-832f-4710-b888-eef5638fc9d45
1095689salicylic acid 275 MG/ML Topical SolutionSCD572171f7-832f-4710-b888-eef5638fc9d45
1095689salicylic acid 27.5 % Topical SolutionSY572171f7-832f-4710-b888-eef5638fc9d45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42192-135-10421920135101 BOTTLE, WITH APPLICATOR in 1 CARTON (42192-135-10) / 10 mL in 1 BOTTLE, WITH APPLICATOR2011-10-102027-07-31NoNoCurrent