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

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 Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 04JA59TNSJ
Rxcui1046378

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

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) 2022-12-20NoNoHistorical