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 74 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOW DOSE ASPIRINASPIRINBryant Ranch Prepack64c28b38-23bb-4c7e-9c19-1d1f0d5975282024-01-18WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLCe0dd4c04-6811-38a1-e053-2995a90aa3c92024-01-17WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENCARDINAL HEALTHbdf8c511-ce25-0e30-e053-2a95a90a33f62024-01-10WarningsExact identifier
application number: M013
Extra Strength Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2560126e-a54a-4a47-9631-a1bca42f52772024-01-10WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINA-S Medication Solutionsee4451c9-4d0f-4373-8f64-fcc1f9dd58562024-01-05WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP51ba690e-d76b-41c6-a083-8bc803e1faa22024-01-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-Aspirin Extra StrengthACETAMINOPHENProficient Rx LP9071b047-5463-4f65-b775-bfb0ce0665272024-01-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
application number: M013
MAX Cold, Flu, and Sore ThroatACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCLH E B9b09b660-0758-48dc-84c9-26cdd2aacc032023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.e6c3e545-b2ad-47f0-8318-c134a8e24f5b2023-12-29WarningsExact identifier
application number: M013
Daytime Non-Drowsy COLD/FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESalado Sales, Inc.e181b371-78c7-4163-865d-acc064be33ca2023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever Cherry flavorACETAMINOPHENWalgreen Company64c65244-f7a3-401b-b83a-bf66d45268e22023-12-29WarningsExact identifier
application number: M013
Nite-Time COLD/FLU ORIGINALACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.fcd24753-b42b-4d05-8379-0ec0351ab2172023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU CherryACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Baskete772cdf5-d01d-4752-8cfb-7e7f4d7a8dd02023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever, Grape flavorACETAMINOPHENWalgreen Company0995d69f-61aa-40b0-b095-bb8595caf7732023-12-29WarningsExact identifier
application number: M013
DAY-TIME Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketce900e42-d0c8-408d-a1c3-3a9bef1c97ee2023-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLDOLGENCORP, INC.06553550-5685-f3c3-e063-6394a90aef072023-12-22WarningsExact identifier
application number: M013
Tension Headache Pain Relieving AidACETAMINOPHEN,CAFFEINEWAL-MART STORES INC00fadd26-a6eb-dc5e-e063-6394a90a3cca2023-12-15WarningsExact identifier
application number: M013
Dye-Free Aspirin 81ASPIRINWALGREENSd71a9d3a-cd28-14a8-e053-2995a90a832b2023-12-15WarningsExact 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