FDA.reportPublic FDA data

Panadol

Product NDC
0135-7031
11-digit product format
001357031
Labeler code
0135
Product ID
0135-7031_1cbe5e2d-4776-3d99-e063-6294a90a10a9
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen and phenyleprine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-20
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
Cold and Flu NonDrowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046378Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa0ce51f-441d-4409-8617-b3402b00f187Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-7031-01PanadolCold and Flu NonDrowsy2 in 1 PACKETTABLET, FILM COATED24
0135-7031-01PanadolCold and Flu NonDrowsy50 in 1 CARTONTABLET, FILM COATED504
0135-7031-02PanadolCold and Flu NonDrowsy24 in 1 BLISTER PACKTABLET, FILM COATED244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-7031PANADOL COLD AND FLU NONDROWSY (ACETAMINOPHEN AND PHENYLEPRINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 3 package rows20240709_fa0ce51f-441d-4409-8617-b3402b00f187.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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINCardinal Health 110, LLC. DBA Leader318cc982-23a9-4804-b6fb-248f772d7a382026-04-02WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader8a18565c-b84e-43f8-8e96-e1dbcc39f08b2026-04-02WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENH E Bc713556c-cb9e-4ed2-bc2f-49b3d6256c0f2026-04-02WarningsExact identifier
application number: M013
AspirinASPIRINDiscount Drug Mart4a1e9c79-5036-4c69-82f9-e48abc972b472026-04-02WarningsExact identifier
application number: M013
WispirinASPIRINWisdrug AG4e70ec5e-d033-a525-e063-6394a90a5a932026-04-01WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leaderef2d75ee-9ed7-4b53-adbc-2ec40364da632026-03-31WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEHi-Tech Nutraceuticals, LLCb119ba37-0ee3-851a-e053-2995a90a85b12026-03-31WarningsExact identifier
application number: M013
AspirinASPIRINRMT HEALTH LLC4dc7229d-c895-1f80-e063-6394a90abfc32026-03-30WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.d1f05e56-c830-4f85-b685-2a5965d10a1c2026-03-26WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackad01aea6-4af3-469b-b99d-e1e66aa40e8d2026-03-25WarningsExact identifier
application number: M013
aspirinASPIRINMeijer Distribution Incc550b92e-de54-4599-9534-bd3022b0a86d2026-03-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAmerisourceBergen (Good Neighbor Pharmacy) 46122db187226-0770-4934-90a4-c6ca50bdecef2026-03-25WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)804d4b63-1bbe-47c0-ad49-39ddbeade6a32026-03-25WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENHyVee Inc9d9c2bf6-8660-4987-8794-936d3102da8d2026-03-24WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENBJWC (Berkley & Jensen / BJ's)851228ea-eaf3-452b-a9ce-8cd244a0eaf32026-03-24WarningsExact identifier
application number: M013
FirstCare Childrens Pain Fever AcetaminophenACETAMINOPHEN 80 MGUSpharma Ltd9fc05ba6-5667-457e-82c1-a8b4e16cadda2026-03-23WarningsExact identifier
application number: M013
AspirinASPIRINAarkish Pharmaceuticals NJ Inc.e5e9e1ce-666a-461f-8287-a4642902067c2026-03-23WarningsExact identifier
application number: M013
Chewable Aspirin Low DoseCHEWABLE ASPIRINGrocery Outlet609c0389-8bed-4483-84fa-73ee73fdb4e42026-03-20WarningsExact identifier
application number: M013
Adult Low Dose Pain RelieverASPIRINTWIN MED LLCa395acf4-f487-4c98-8c44-ca2aaaf72deb2026-03-20WarningsExact identifier
application number: M013
RapidolACETAMINOPHENPharmadel LLC3a210860-1fc1-e496-e063-6394a90a87052026-03-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNfa0ce51f-441d-4409-8617-b3402b00f1874
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDfa0ce51f-441d-4409-8617-b3402b00f1874
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYfa0ce51f-441d-4409-8617-b3402b00f1874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-7031-010013570310150 PACKET in 1 CARTON (0135-7031-01) / 2 TABLET, FILM COATED in 1 PACKET50 packet2022-12-200000-00-00NoNoCurrent
0135-7031-020013570310224 TABLET, FILM COATED in 1 BLISTER PACK (0135-7031-02) 2022-12-20NoNoCurrent