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 60 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Regular StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI1462b308-a6a5-49ca-ab29-cacbf62caf0b2024-10-17WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf3db8598-fe0e-4c53-a023-5f5f8f002cc62024-10-17WarningsExact identifier
application number: M013
acetaminophen pm extra strengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIf86a11af-6d3c-4638-870d-a663ddf493712024-10-17WarningsExact identifier
application number: M013
Acetaminophen Gelcaps Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI3588a3ef-a493-43ed-96e0-c259f0d087db2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCa2186895-944b-48cb-b3c2-eac208866c342024-10-17WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC6a5d43c8-f4b7-4447-b2e1-53eb12208ef02024-10-17WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC32cc6e05-84c1-4710-bebc-cb6e7133dc542024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC2ca87a29-1f54-4da4-a66f-3b3dd4f0396c2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e2024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINKroger Company453f62d5-f580-4d19-bfae-4f78c2a6b6d62024-10-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA Store Inc.ec6add55-f4a3-7818-e053-2a95a90aee042024-10-16WarningsExact identifier
application number: M013
ASPIRINASPIRINFSA Store Inc.062e7b7b-d052-82b0-e063-6294a90a7cce2024-10-16WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.f4322f34-ac19-371e-e053-2a95a90ac8642024-10-16WarningsExact identifier
application number: M013
Low dose Chewable AspirinASPIRINFSA STORE INC.f939b44c-93b6-ca61-e053-6394a90ae5862024-10-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART850b5ad8-8774-413c-ae38-022215a94f952024-10-16WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINDISCOUNT DRUG MARTaf0f50d2-3e2d-f723-e053-2995a90a0d4b2024-10-16WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINDISCOUNT DRUG MART03ed19dd-1cfc-47d5-b83e-ffa2ebe93f482024-10-16WarningsExact identifier
application number: M013
PAIN RELIEF Regular StrengthACETAMINOPHENAMERICAN SALES COMPANY2e3eabc8-193b-4397-a43c-db838eb16e672024-10-15WarningsExact identifier
application number: M013
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact 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