FDA.reportPublic FDA data

APAP

Product NDC
17714-013
11-digit product format
177140013
Labeler code
17714
Product ID
17714-013_60f41580-e099-faad-e053-2a91aa0a9076
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Advance Pharmaceutical Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1989-02-05
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aba26f0a-94e4-4919-a3b0-033e3a9598efAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17714-013-01APAP100 in 1 BOTTLETABLET1002
17714-013-10APAP1000 in 1 BOTTLETABLET10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DAPAP (ACETAMINOPHEN) TABLET [ADVANCE PHARMACEUTICAL INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DAPAP (ACETAMINOPHEN) TABLET [ADVANCE PHARMACEUTICAL INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EAPAP (ACETAMINOPHEN) TABLET [ADVANCE PHARMACEUTICAL INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2APAP (ACETAMINOPHEN) TABLET [ADVANCE PHARMACEUTICAL INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAPAP (ACETAMINOPHEN) TABLET [ADVANCE PHARMACEUTICAL INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAPAP (ACETAMINOPHEN) TABLET [ADVANCE PHARMACEUTICAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-013APAP (ACETAMINOPHEN) TABLET [ADVANCE PHARMACEUTICAL INC.]2Current NDC, Legacy NDC, 2 package rows20171223_aba26f0a-94e4-4919-a3b0-033e3a9598ef.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
APAPACETAMINOPHENAdvance Pharmaceutical Inc.aba26f0a-94e4-4919-a3b0-033e3a9598ef2017-12-22WarningsExact identifier
ndc (product): 17714-013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNaba26f0a-94e4-4919-a3b0-033e3a9598ef2
198440acetaminophen 500 MG Oral TabletSCDaba26f0a-94e4-4919-a3b0-033e3a9598ef2
198440APAP 500 MG Oral TabletSYaba26f0a-94e4-4919-a3b0-033e3a9598ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17714-013-0117714001301100 TABLET in 1 BOTTLE (17714-013-01) 100 tablet1989-02-050000-00-00NoNoCurrent
17714-013-10177140013101000 TABLET in 1 BOTTLE (17714-013-10) 1000 tablet1989-02-050000-00-00NoNoCurrent