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 48 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin 81 mg	ASPIRIN	Asclemed USA, Inc.	878dab20-668b-4d7a-a5f8-794a587564d5	2025-02-13	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CVS HEALTH CORP	bbc48c9e-7eb8-2c67-e053-2a95a90a8552	2025-02-13	Warnings	Exact identifier application number: M013
Dye Free Infants Pain and Fever	ACETAMINOPHEN	CVS	1fde0f7c-4b5b-ae9c-e063-6394a90afa41	2025-02-13	Warnings	Exact identifier application number: M013
NOTTS - Extra Strength 500 mg	ACETAMINOPHEN	VIVUNT PHARMA LLC	e677f43d-b4ce-e5b0-e053-2a95a90ad67e	2025-02-12	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	LEADER/ Cardinal Health 110, Inc.	b3773f02-02a9-33c8-e053-2995a90a2235	2025-02-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	c9f80d24-bd05-e1ce-e053-2995a90aa646	2025-02-10	Warnings	Exact identifier application number: M013
Low dose Aspirin	ASPIRIN 81 MG DELAYED RELEASE TABLETS	WALGREENS	c25c55aa-9932-0a55-e053-2a95a90a3d1e	2025-02-10	Warnings	Exact identifier application number: M013
AeroTab Pain Reliever	PAIN RELIEVER	Aero Healthcare	40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f	2025-02-10	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin Regular Strength	ASPIRIN	Time-Cap Labs, Inc	5fbd8bb3-46f9-4089-9a21-b6af97a06106	2025-02-08	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABS INC	c193dbc0-cc80-4a7c-aa29-457a20edf835	2025-02-08	Warnings	Exact identifier application number: M013
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	22f23aeb-f874-6e54-e063-6394a90a9565	2025-02-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3008928-c555-64ad-e053-2995a90a7307	2025-02-05	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300dfbc-7137-79d1-e053-2995a90a636e	2025-02-05	Warnings	Exact identifier application number: M013
Low dose aspirin 81mg	ASPIRIN	BETTER LIVING BRANDS LLC.	f300c30b-ab1a-a1b4-e053-2a95a90a1294	2025-02-05	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	5d174187-cf89-41ff-9a64-10e0276daf17	2025-02-05	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	Bryant Ranch Prepack	c226205d-7c3c-49af-b3e2-fc7b09ad7857	2025-02-05	Warnings	Exact identifier application number: M013
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	a69fca9d-c0a0-4321-bf03-5c8e99cc07cc	2025-02-04	Warnings	Exact identifier application number: M013
TENSION HEADACHE RELIEF	ACETAMINOPHEN-CAFFEINE	TARGET CORPORATION	8ed1679d-d3a1-11b1-e053-2995a90a61ad	2025-01-31	Warnings	Exact identifier application number: M013
ValuMeds Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Cabinet Health P.B.C.	0f864e73-e4b8-4e23-8990-8439ac17bd58	2025-01-31	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN TABLETS 500 MG	WALGREENS	c25bfe92-0196-0489-e053-2995a90abea1	2025-01-30	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