Panadol

Product NDC: 0135-0607
11-digit product format: 001350607
Labeler code: 0135
Product ID: 0135-0607_10c08cd4-8a3b-c9ad-e063-6394a90a9641
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: 2017-06-01
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f626ab17-01c9-4493-ba9e-0c8c11146384	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0135-0607-02	2020-07-22	C162847	48780-1	ab0e2407-34ee-f274-e053-dbdaa90a6471	Drug Facts
0135-0607-03	2020-07-22	C162847	48780-1	ab0e2407-34ee-f274-e053-dbdaa90a6471	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0607-01	PanadolCold and Flu NonDrowsy	2 in 1 PACKET	TABLET, FILM COATED	2	6
0135-0607-02	PanadolCold and Flu NonDrowsy	3 in 1 CARTON	TABLET, FILM COATED	3	6
0135-0607-02	PanadolCold and Flu NonDrowsy	8 in 1 BLISTER PACK	TABLET, FILM COATED	8	6
0135-0607-03	PanadolCold and Flu NonDrowsy	50 in 1 CARTON	TABLET, FILM COATED	50	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0607-02	EA - Each	0135-0607	3d20babd-8f09-4f9a-a49a-c498993637c6	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0607	PANADOL COLD AND FLU NONDROWSY (ACETAMINOPHEN AND PHENYLEPRINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC]	6	Current NDC, Legacy NDC, 4 package rows	20240207_f626ab17-01c9-4493-ba9e-0c8c11146384.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 67 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	18ff2df8-ee65-4219-ad93-cf5090bfac2d	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	9fdbaf5e-f88b-4d18-97df-0b2e8dddf377	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	bfb9af64-3195-44bf-bcf3-6b36b40d3cc7	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1ac7ed71-5afe-d09c-e063-6294a90a3b88	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ce5bbf2-d449-464e-abeb-5c26866d1ab5	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	3f73a359-59d7-47bb-872e-914b0db719af	2024-06-13	Warnings	Exact identifier application number: M013
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	2024-06-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	026bf664-d598-73de-e063-6394a90a9206	2024-06-12	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	7c73fc75-af9b-177c-e053-2a91aa0ada56	2024-06-12	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Topco Associates	4a6a1dbb-c813-42fd-9bb8-497aec339466	2024-06-11	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	fa234639-caf8-4c52-9ffe-f1c0c057ee5b	2024-06-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	bc18590d-6481-4efe-8a3b-974f7543b754	2024-06-10	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	H-E-B	085b35db-62e4-38db-e063-6394a90a9763	2024-06-07	Warnings	Exact identifier application number: M013
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	5691ac45-5732-412e-abb8-2bfaac59160e	2024-06-07	Warnings	Exact identifier application number: M013
Cafiaspirina Rapid Headache Relief	ASPIRIN, CAFFEINE	Belmora LLC	d890acec-6528-4fb7-8d59-6c572a3f0786	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	TARGET Corporation	611bc1ce-460a-44a3-8e2d-b28a399d9a44	2024-06-06	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	033a6153-2651-4703-8a94-def461838113	2024-06-05	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046378	acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f626ab17-01c9-4493-ba9e-0c8c11146384	6
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f626ab17-01c9-4493-ba9e-0c8c11146384	6
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	f626ab17-01c9-4493-ba9e-0c8c11146384	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0607-01	00135060701	2 in 1 PACKET						Historical
0135-0607-02	00135060702	3 BLISTER PACK in 1 CARTON (0135-0607-02) / 8 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2017-06-01	0000-00-00	No	No	Current
0135-0607-03	00135060703	50 PACKET in 1 CARTON (0135-0607-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0607-01)	50 packet	2017-06-01	0000-00-00	No	No	Current