Pain Reliever

Product NDC
49035-919
11-digit product format
490350919
Labeler code
49035
Product ID
49035-919_d9aaffe0-1e65-4716-93b9-c344370e2c07
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-26
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
Pain Reliever
Brand name suffix
Extra Strength
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
72365264-f9c4-49f0-be64-73d95817d358Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-919-08Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED18
49035-919-08Pain RelieverExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED248
49035-919-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1008
49035-919-20Pain RelieverExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED2258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-919-12EA - Each49035-91997fe4d0b-fb1f-4cb9-b1d0-691b521a798612023-04-07
49035-919-20EA - Each49035-919d5cced46-9f44-4003-a577-0e6748ba22be12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-919PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WAL-MART STORES INC]6Current NDC, Legacy NDC, 4 package rows20241027_72365264-f9c4-49f0-be64-73d95817d358.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 23 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINHYVEE INC3e602287-565e-a5b9-e063-6294a90abc172026-01-13WarningsExact identifier
application number: M013
ASPIRIN DELAYED RELEASE 81MGASPIRIN DELAYED RELEASE 81MGFarmacias De Similares TX LLC3a8a3efc-f0b3-411c-e063-6394a90a84b72026-01-13WarningsExact identifier
application number: M013
Chewable Aspirin 81 mgASPIRINHYVEE INC459f749f-9d23-8752-e063-6394a90a8c812026-01-13WarningsExact identifier
application number: M013
ASPIRIN 325 mgASPIRINHYVEE INC459d01df-6ff6-cff6-e063-6394a90ab35c2026-01-13WarningsExact identifier
application number: M013
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
application number: M013
Aspirin PacksASPIRINSina Health Inc2865a2c3-53fc-ab9a-e063-6394a90a14182026-01-12WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.64696f65-415e-4ce1-a5b3-70662fbcb0022026-01-12WarningsExact identifier
application number: M013
Aspirin enteric coated low doseASPIRINWalgreen Company186a6270-e3de-4499-88a4-5f723fee3e342026-01-12WarningsExact identifier
application number: M013
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINFamily Dollar Services Incd35d798e-76f1-454d-86f6-ad11c3bf17d82026-01-12WarningsExact identifier
application number: M013
Xpect AcetaminophenACETAMINOPHENCintas Corporationf4aed854-730e-493d-b523-122156e08dde2026-01-09WarningsExact identifier
application number: M013
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
application number: M013
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
application number: M013
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergenc3099892-a8cd-4574-a6f9-041e59e2feae2026-01-07WarningsExact identifier
application number: M013
Bactimicina Childrens Pain and FeverACETAMINOPHENDLC Laboratories, Inc.bdade270-d813-4178-b594-4951632b68392026-01-07WarningsExact identifier
application number: M013
Goodmeds Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.02c60967-46d7-49b7-82be-bc3c5fd364842026-01-06WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEa73f8217-9eae-4e2a-b29c-7de3861d0e372026-01-06WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporationf77f0120-4042-4b11-ba9c-cd35e1cd0bee2026-01-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN72365264-f9c4-49f0-be64-73d95817d3588
198440acetaminophen 500 MG Oral TabletSCD72365264-f9c4-49f0-be64-73d95817d3588
198440APAP 500 MG Oral TabletSY72365264-f9c4-49f0-be64-73d95817d3588

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-919-08490350919081 BOTTLE, PLASTIC in 1 CARTON (49035-919-08) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2019-11-260000-00-00NoNoCurrent
49035-919-1249035091912100 TABLET, COATED in 1 BOTTLE, PLASTIC (49035-919-12) 2019-11-260000-00-00NoNoCurrent
49035-919-2049035091920225 TABLET, COATED in 1 BOTTLE, PLASTIC (49035-919-20) 2019-11-260000-00-00NoNoCurrent