FDA.reportPublic FDA data

EXTRA STRENGTH ACETAMINOPHEN

Product NDC
79903-032
11-digit product format
799030032
Labeler code
79903
Product ID
79903-032_495e1164-7604-42c2-e063-6394a90aa96d
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-05
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
EXTRA STRENGTH 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
a88eba4c-0701-4eec-9a24-a804186fbfd8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-032-01EXTRA STRENGTH ACETAMINOPHEN100 in 1 BOTTLETABLET1009
79903-032-02EXTRA STRENGTH ACETAMINOPHEN2 in 1 CARTONTABLET29
79903-032-10EXTRA STRENGTH ACETAMINOPHEN100 in 1 BOTTLETABLET1009
79903-032-40EXTRA STRENGTH ACETAMINOPHEN1 in 1 CARTONTABLET19
79903-032-40EXTRA STRENGTH ACETAMINOPHEN40 in 1 BOTTLETABLET409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79903-032-02EA - Each79903-032a10a10d5-5af2-4301-8812-8416ef5a93c112023-09-05
79903-032-10EA - Each79903-032efb4f630-797b-4a17-94d1-02abfd986a3512022-12-07
79903-032-40EA - Each79903-0324422bb8e-0e56-4f3a-af3e-a7762b7f005012022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-032EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [WAL-MART STORES INC]7Current NDC, Legacy NDC, 5 package rows20250101_a88eba4c-0701-4eec-9a24-a804186fbfd8.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 61 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Infants Pain and FeverACETAMINOPHENWalgreen Company9e08eb38-7538-4fa0-a0e1-047ab6cb16802024-10-15WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPUBLIX SUPER MARKETS INC9e779cc6-4641-6132-e053-2a95a90a34932024-10-11WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENCHAIN DRUG CONSORTIUM5c1a3081-ae25-4895-bf76-ebcbb9fc80722024-10-11WarningsExact identifier
application number: M013
Aspirin 81 MGASPIRINMeijerb3e5711c-9529-4eec-871d-de8efa858b862024-10-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INC9586e830-a285-4a07-8b34-9698754423482024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association68a52858-35c5-402a-8ceb-8d8a7c1e5f6c2024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association5de40821-3218-4320-bf11-9493bf01d4892024-10-11WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association475becec-1a56-4cfa-a0c5-562f8772adfb2024-10-11WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENTopco Associates LLC6036c15b-1168-4103-9471-6a74a2140e532024-10-10WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
application number: M013
dg health aspirinASPIRINDolgencorp, LLC0ab34dc7-0110-4fc3-ae53-234e7d7bca3c2024-10-07WarningsExact identifier
application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.19ba1fb6-22ea-488e-9e52-94c14ceb80d12024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINStrategic Sourcing Services LLC4d66a8a8-a1c1-4430-8845-21ae67700c392024-10-07WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderca603b12-e0f7-4d79-8e0d-4651a788ba9b2024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINMcKesson Medical-Surgical, Inc.e9342478-93d6-45de-948f-f4162ee675b22024-10-07WarningsExact identifier
application number: M013
Maximum Strength Backache ReliefMAGNESIUM SALICYLATEJHK DBA American Safety & First Aidf8cbcd4e-cfad-4592-8774-52e681494c452024-10-07WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORNavajo Manufacturing Company Inc.f70875ab-241c-4876-e053-6294a90a80922024-10-03WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.86b6ac01-3866-4cd8-a1be-9babb6ff311b2024-10-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa88eba4c-0701-4eec-9a24-a804186fbfd89
198440acetaminophen 500 MG Oral TabletSCDa88eba4c-0701-4eec-9a24-a804186fbfd89
198440APAP 500 MG Oral TabletSYa88eba4c-0701-4eec-9a24-a804186fbfd89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79903-032-0179903003201100 in 1 BOTTLEHistorical
79903-032-02799030032022 BOTTLE in 1 CARTON (79903-032-02) / 100 TABLET in 1 BOTTLE (79903-032-01) 2 bottle2021-01-122028-09-30NoNoCurrent
79903-032-1079903003210100 TABLET in 1 BOTTLE (79903-032-10) 100 tablet2021-01-120000-00-00NoNoCurrent
79903-032-40799030032401 BOTTLE in 1 CARTON (79903-032-40) / 40 TABLET in 1 BOTTLE1 bottle2021-01-122029-04-30NoNoCurrent