Pain Relief

Product NDC
53943-104
11-digit product format
539430104
Labeler code
53943
Product ID
53943-104_288cbf57-1697-5f70-e063-6394a90af83b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-01
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
Pain Relief
Brand name suffix
Extra Strength
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
e6fee238-0b6f-cb84-e053-2995a90a361bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-104-02Pain ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED503
53943-104-02Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
53943-104-04Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003
53943-104-04Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
53943-104-06Pain ReliefExtra Strength500 in 1 BOTTLE, PLASTICTABLET, COATED5003
53943-104-09Pain ReliefExtra Strength2 in 1 CARTONTABLET, COATED23
53943-104-09Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-104PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [DISCOUNT DRUG MART]3Current NDC, Legacy NDC, 7 package rows20241208_e6fee238-0b6f-cb84-e053-2995a90a361b.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 85 · 1,687 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
application number: M013
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
application number: M013
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
application number: M013
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
application number: M013
Extra Strength Pain Reliever mini softgelsACETAMINOPHEN 500 MGShield Pharmaceuticals Corp0ebb1902-6f8a-4bfb-9f2e-839d43bfca372026-08-04WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENBetter Living Brands, LLC743af02c-c762-42f5-8e01-2f62da15e04e2026-08-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC9aea8aae-8702-4c93-8b07-69cd252f44d62026-08-03WarningsExact identifier
application number: M013
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-08-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNe6fee238-0b6f-cb84-e053-2995a90a361b3
198440acetaminophen 500 MG Oral TabletSCDe6fee238-0b6f-cb84-e053-2995a90a361b3
198440APAP 500 MG Oral TabletSYe6fee238-0b6f-cb84-e053-2995a90a361b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-104-02539430104021 BOTTLE, PLASTIC in 1 CARTON (53943-104-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2022-10-010000-00-00NoNoCurrent
53943-104-04539430104041 BOTTLE, PLASTIC in 1 CARTON (53943-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2022-10-010000-00-00NoNoCurrent
53943-104-0653943010406500 TABLET, COATED in 1 BOTTLE, PLASTIC (53943-104-06) 2022-10-010000-00-00NoNoCurrent
53943-104-09539430104092 BOTTLE, PLASTIC in 1 CARTON (53943-104-09) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2022-10-010000-00-00NoNoCurrent