Pain Reliever

Product NDC
0363-0175
11-digit product format
003630175
Labeler code
0363
Product ID
0363-0175_9b25babe-5e4e-459f-ac51-6515648f3587
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-04-02
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-01750363-0175-08DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-12DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-14DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-15DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-20DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-29DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-37DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-57DDiscontinued by firm2026-10-16
excluded packagepackage0363-01750363-0175-99DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 104 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050363-0175-99d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-57d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-29d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0175-37d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-57f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-37f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-99f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0175-29f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-572ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-372ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-992ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0175-292ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-57a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-37a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0175-29a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-57cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-37cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-99cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0175-29cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-57cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-37cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-99cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0175-29cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310363-0175-57302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0175-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0175-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0175-37302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0175-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0175-99302b2466d912…e7b80fea0513…

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
f7667529-09c0-4603-8080-f236144fac36Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0175-03Pain RelieverExtra Strength10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1025
0363-0175-08Pain RelieverExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2425
0363-0175-08Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10025
0363-0175-12Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-14Pain RelieverExtra Strength500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50025
0363-0175-15Pain RelieverExtra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5025
0363-0175-15Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-20Pain RelieverExtra Strength225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22525
0363-0175-20Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-29Pain RelieverExtra Strength150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15025
0363-0175-37Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-37Pain RelieverExtra Strength75 in 1 BOTTLE, PLASTICTABLET, FILM COATED7525
0363-0175-57Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-57Pain RelieverExtra Strength125 in 1 BOTTLE, PLASTICTABLET, FILM COATED12525
0363-0175-99Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-99Pain RelieverExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2425

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0175-08EA - Each0363-01751785b67f-dae5-4bd7-bf49-2a18c917a43e12012-07-24
0363-0175-12EA - Each0363-0175080c808e-3a8b-4c5a-af0b-4434d903ebe412012-07-24
0363-0175-14EA - Each0363-0175f746f447-21e4-460f-9c02-1cd1136c4b1612012-07-24
0363-0175-15EA - Each0363-01757ab0b567-db1d-444e-81aa-21757e7a18cf12012-07-24
0363-0175-20EA - Each0363-017542a2211c-bd60-46b4-8d2b-42ceba0f637b12024-04-05
0363-0175-29EA - Each0363-01752ae5278f-300e-48a0-851e-4d1feb4cb91612012-07-24
0363-0175-37EA - Each0363-01753d03849d-5174-498a-8e5c-3e4507212a0412024-04-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0175PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN COMPANY]24Current NDC, Legacy NDC, 17 package rows20250108_f7667529-09c0-4603-8080-f236144fac36.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 24 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual Relief Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEUnited Natural Foods, Inc. dba UNFI807598ef-9f03-48df-b076-3ee95ef4b06c2026-01-05WarningsExact identifier
application number: M013
Pain Relief Extra Strength, Non-AspirinACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1fb5e871-45fd-46fe-bf73-5192f8316e8e2026-01-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENValu Merchandisers Company0005aafa-08f8-4990-a54d-cc097195708f2026-01-02WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENWalmart Inc.152bb455-da5b-ae13-e063-6394a90acab02026-01-01WarningsExact identifier
application number: M013
Dr. Cocoa for Children Pain and FeverACETAMINOPHENInfirst Healthcare Inc.486ea294-6d18-a907-e063-6294a90ad2842026-01-01WarningsExact identifier
application number: M013
ED APAPACETAMINOPHENEDWARDS PHARMACEUTICALS, INC.f76d5fff-ebea-40f9-aad3-4064a0c863f02025-12-31WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP99ec63ef-aa28-c2fb-e053-2a95a90a9f6d2025-12-31WarningsExact identifier
application number: M013
Puregen Labs AcetaminophenACETAMINOPHENAdvanced Rx LLC474580af-f6b0-e440-e063-6394a90aaada2025-12-31WarningsExact identifier
application number: M013
Liquid AcetaminophenACETAMINOPHENLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONa7dbd4c0-53eb-4368-917b-1432c09ce6b42025-12-31WarningsExact identifier
application number: M013
Llorens Care Children AcetaminophenACETAMINOPHENLlorens Pharmaceutical International Division, Inc.2a46d7d2-293b-5024-e063-6294a90a31aa2025-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)Walgreens3a801457-c5d0-b134-e063-6294a90ac5cb2025-12-31WarningsExact identifier
application number: M013
Daytime and Nighttime Severe Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGenexa Inc.190c7eaf-dcd4-d314-e063-6294a90a6f332025-12-30WarningsExact identifier
application number: M013
BioElectro Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEGenomma Lab USA683a0fba-921c-48e7-a391-180c04f0d1c42025-12-30WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLC0181af13-da32-4431-be39-c31fdfac92022025-12-29WarningsExact identifier
application number: M013
Gemma Cut the CrampASPIRIN, CAFFEINERally Labs LLC16c9a296-077a-8e12-e063-6294a90a1b8b2025-12-29WarningsExact identifier
application number: M013
BlowfishASPIRIN, CAFFEINERally Labs LLC0d3798bc-04ef-584e-821b-7aa76036b7d12025-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension CherryACETAMINOPHENPuro Pharma Inc.a2afaee7-19f3-4a42-a5b8-1d0ef3ecf0092025-12-27WarningsExact identifier
application number: M013
Cystex PMACETAMINOPHEN, DIPHENHYDRAMINE HCLClarion Brands, LLC9668a2ca-729e-4172-80b5-33e6c5175ba42025-12-27WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf7667529-09c0-4603-8080-f236144fac3625
198440acetaminophen 500 MG Oral TabletSCDf7667529-09c0-4603-8080-f236144fac3625
198440APAP 500 MG Oral TabletSYf7667529-09c0-4603-8080-f236144fac3625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0175-030036301750310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-03) 1993-04-020000-00-00NoNoCurrent
0363-0175-08003630175081 BOTTLE, PLASTIC in 1 CARTON (0363-0175-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-12003630175121 BOTTLE, PLASTIC in 1 CARTON (0363-0175-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-1400363017514500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-14) 1993-04-020000-00-00NoNoCurrent
0363-0175-15003630175151 BOTTLE, PLASTIC in 1 CARTON (0363-0175-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-20003630175201 BOTTLE, PLASTIC in 1 CARTON (0363-0175-20) > 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-2900363017529150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-29) 1993-04-020000-00-00NoNoCurrent
0363-0175-37003630175371 in 1 CARTONHistorical
0363-0175-57003630175571 in 1 CARTONHistorical
0363-0175-99003630175991 BOTTLE, PLASTIC in 1 CARTON (0363-0175-99) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent