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 50 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRIN 325MGUlai Health LLC26942d32-d6e6-464d-8fc4-ffd9806d3e622025-01-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INCa354b24e-0913-829f-e053-2995a90ad4072025-01-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INC8f221fdb-8138-c1a8-e053-2995a90a29c22025-01-11WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions3294ba24-f198-485e-88fc-435964434b802025-01-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals32ea1230-f9ae-46b0-910e-05cd187cee342025-01-09WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLCe817bc4a-43ef-4126-b903-aabd1390cd0c2025-01-08WarningsExact identifier
application number: M013
GeriCare Liquid Pain ReliefACETAMINOPHENGeri-Care Pharmaceuticals, Corp85a074da-14b7-4db5-9d47-8ad19f5207212025-01-06WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINMeijer Distribution Inceb29d6be-f095-44b2-b6ed-7e4167b596f82025-01-02WarningsExact identifier
application number: M013
Headache, Circle KACETAMINOPHEN, CAFFEINE, ASPIRIN TABLETLil' Drug Store Products, Inc.e711ff0a-2fa0-1f2a-e053-2a95a90a4e382024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Lil Drug StoreEXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0c41deda-490b-f5d2-e063-6394a90a50472024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Circle KACETAMINOPHEN/ASPIRIN/CAFFEINE TABLETLil' Drug Store Products, Inc.d18e1631-de43-4b29-e053-2995a90af56d2024-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED TABLETLil' Drug Store Products, Inc.e5f9def4-4cf5-4e06-e053-2995a90a07ea2024-12-31WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp6158e954-32d8-4718-e053-2a91aa0a27f32024-12-31WarningsExact identifier
application number: M013
AspirinASPIRINAdvanced Rx Pharmacy of Tennessee, LLCf8375029-e567-c6a5-e053-6394a90a5b672024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEDollar General4907056d-6013-46b1-ae86-469dc30015912024-12-31WarningsExact identifier
application number: M013
Pediacare Childrens GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHf9d531a2-234c-4feb-8f05-212dbee83dfe2024-12-30WarningsExact 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