FDA.reportPublic FDA data

Acetaminophen

Product NDC
0615-8610
11-digit product format
006158610
Labeler code
0615
Product ID
0615-8610_4e18d785-6ccf-4f42-b6bc-e8ff4364e149
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-09
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Acetaminophen
Listing expiration
2027-12-31

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
f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8610-05Acetaminophen15 in 1 BLISTER PACKTABLET, FILM COATED151
0615-8610-30Acetaminophen5 in 1 BLISTER PACKTABLET, FILM COATED51
0615-8610-30Acetaminophen6 in 1 BOX, UNIT-DOSETABLET, FILM COATED61
0615-8610-39Acetaminophen30 in 1 BLISTER PACKTABLET, FILM COATED301

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 78 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.f06fe167-8a16-14d9-e053-2a95a90a1a0f2023-10-17WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENBLESSINGS INTERNATIONALee8ba190-2c42-7ca2-e053-2a95a90a01a02023-10-17WarningsExact identifier
application number: M013
AphenACETAMINOPHENAsclemed USA, Inc.fe3c0a2b-316b-4620-b6bc-378dbaf7ed572023-10-16WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreensb4b06d32-6a09-4c43-980b-377b617ba7392023-10-09WarningsExact identifier
application number: M013
FLO PMS CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEO Positiv, Inc.cce62d9f-adb1-4473-8258-910dff6b13782023-10-09WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENProficient Rx LP88c4183a-3032-46de-bf18-f700055f617b2023-10-01WarningsExact identifier
application number: M013
Tri-Buffered AspirinASPIRINProficient Rx LP640c3311-2abf-40b2-82b9-9fe4d8c1cf1d2023-10-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC852e70e2-7279-6f33-e053-2991aa0a86762023-08-28WarningsExact identifier
application number: M013
Children Pain ReliefCHILDREN PAIN RELIEFAllegiant Health44c90cbe-8ece-4dd8-9ea5-7f8d6f4c00962023-07-17WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINBetter Living Brands LLC4a76e898-3204-4f77-bc67-c19f5fe829f32023-07-05WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGLodaat LLC04017bc9-602a-4204-96a9-b7f9713155f62023-01-31WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINWALGREENSd71a22e8-9e39-a672-e053-2a95a90a14032022-07-08WarningsExact identifier
application number: M013
Pain Relief Extra StrengthPAIN RELIEFAllegiant Healthd41d2319-8eed-4df9-813c-313497ceb8b42021-11-23WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthPAIN RELIEF PMAllegiant Health4c9969be-a01f-4ca4-800a-e404229ce28b2021-11-23WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Health9d348550-060b-410f-8c1e-8f43d00b860e2021-11-22WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin RegimenASPIRINAllegiant Health847fd2f8-2e32-4ef2-a793-b902045110f12021-11-19WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINAllegiant Healthd6c7c8c9-b997-4acc-a066-133bfb1239cb2021-11-02WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINDr. Wayne'seacbdf9e-5642-4986-a03c-b0812d28265d2021-11-02WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin RegimenASPIRINAllegiant Healthd9abe780-7e58-43d8-848f-c6c8893aea2e2021-10-14WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500MGAllegiant Health0f72be92-fac0-4be4-87a3-3f20f0f01db52021-05-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf32fc2e9-c0e3-4a25-8399-9cdba6ae8a161
198440acetaminophen 500 MG Oral TabletSCDf32fc2e9-c0e3-4a25-8399-9cdba6ae8a161
198440APAP 500 MG Oral TabletSYf32fc2e9-c0e3-4a25-8399-9cdba6ae8a161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8610-050061586100515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8610-05) 2026-02-17NoNoCurrent
0615-8610-30006158610306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8610-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2026-02-12NoNoCurrent
0615-8610-390061586103930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8610-39) 2026-01-30NoNoCurrent