PANADOL

Product NDC: 0135-0539
11-digit product format: 001350539
Labeler code: 0135
Product ID: 0135-0539_10c14ee5-017b-0434-e063-6394a90af0f4
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-10-15
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
95801755-db54-4ad7-bec1-52671914f6ca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0135-0539-02	PANADOL	1 in 1 CARTON	SUSPENSION	1		10
0135-0539-02	PANADOL	54.7 mL in 1 BOTTLE	SUSPENSION	54.7		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0539-02	ML - Milliliter	0135-0539	1aeed3ea-dda0-40d1-9b63-f192898d2f3e	1	2022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0539	PANADOL (ACETAMINOPHEN) SUSPENSION [HALEON US HOLDINGS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240207_95801755-db54-4ad7-bec1-52671914f6ca.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 · 1,576 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, 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
CareOne Childrens Acetaminophen	ACETAMINOPHEN	American Sales Company	126ee71a-c408-415b-9a43-502337a91055	2024-06-05	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	A-S Medication Solutions	85294a70-3233-4ba5-bc36-ee3f2964aebf	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0539-02	00135053902	1 BOTTLE in 1 CARTON (0135-0539-02) / 54.7 mL in 1 BOTTLE	1 bottle	2012-10-15	0000-00-00	No	No	Current