Home NDC 0135-7031 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 Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046378 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-7031-01 PanadolCold and Flu NonDrowsy 2 in 1 PACKET TABLET, FILM COATED 2 4 0135-7031-01 PanadolCold and Flu NonDrowsy 50 in 1 CARTON TABLET, FILM COATED 50 4 0135-7031-02 PanadolCold and Flu NonDrowsy 24 in 1 BLISTER PACK TABLET, FILM COATED 24 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-7031 PANADOL COLD AND FLU NONDROWSY (ACETAMINOPHEN AND PHENYLEPRINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 4 Current NDC, Legacy NDC, 3 package rows 20240709_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 63 of 79 · 1,576 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0135-7031-01 00135703101 50 PACKET in 1 CARTON (0135-7031-01) / 2 TABLET, FILM COATED in 1 PACKET 50 packet 2022-12-20 0000-00-00 No No Current 0135-7031-02 00135703102 24 TABLET, FILM COATED in 1 BLISTER PACK (0135-7031-02) 2022-12-20 No No Current