FDA.reportPublic FDA data

PANADOL

Product NDC
0135-0609
11-digit product format
001350609
Labeler code
0135
Product ID
0135-0609_10c10ae1-2b66-f708-e063-6394a90a0fca
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-15
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
PANADOL
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
200977Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2fe7f47-1a2e-40ee-8f8f-38f2028dce1bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
0135-0609-01Drug Facts
0135-0609-02Drug Facts
0135-0609-03Drug Facts
0135-0609-04Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0609-01PANADOLExtra Strength24 in 1 BOTTLETABLET, FILM COATED247
0135-0609-01PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
0135-0609-02PANADOLExtra Strength50 in 1 BOTTLETABLET, FILM COATED507
0135-0609-02PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
0135-0609-03PANADOLExtra Strength100 in 1 BOTTLETABLET, FILM COATED1007
0135-0609-03PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
0135-0609-04PANADOLExtra Strength50 in 1 CARTONTABLET, FILM COATED507
0135-0609-05PANADOLExtra Strength2 in 1 PACKETTABLET, FILM COATED27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0609-01EA - Each0135-0609fe1f0735-9843-4fe3-bb42-0a2256c3b2c612022-12-07
0135-0609-02EA - Each0135-06092e35bea5-0a22-4410-ac97-e2465812c2d812022-12-07
0135-0609-03EA - Each0135-0609a22d623d-3cc7-4af6-a98a-fbe4fceff39012022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0609PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 8 package rows20240207_b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7
200977Panadol Extra Strength 500 MG Oral TabletPSNb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7
200977acetaminophen 500 MG Oral Tablet [Panadol]SBDb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7
198440acetaminophen 500 MG Oral TabletSCDb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7
198440APAP 500 MG Oral TabletSYb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7
200977APAP 500 MG Oral Tablet [Panadol]SYb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7
200977Panadol 500 MG Oral TabletSYb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7
200977Panadol Extra Strength 500 MG Oral TabletSYb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0609-01001350609011 BOTTLE in 1 CARTON (0135-0609-01) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-03-150000-00-00NoNoCurrent
0135-0609-02001350609021 BOTTLE in 1 CARTON (0135-0609-02) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-03-150000-00-00NoNoCurrent
0135-0609-03001350609031 BOTTLE in 1 CARTON (0135-0609-03) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-03-150000-00-00NoNoCurrent
0135-0609-040013506090450 PACKET in 1 CARTON (0135-0609-04) / 2 TABLET, FILM COATED in 1 PACKET (0135-0609-05) 50 packet2017-03-150000-00-00NoNoCurrent
0135-0609-05001350609052 in 1 PACKETHistorical