PANADOL

Product NDC: 0135-0537
11-digit product format: 001350537
Labeler code: 0135
Product ID: 0135-0537_10c0504e-269e-b058-e063-6394a90a5b84
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0135-0537	0135-0537-02	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
e1799765-c247-42b4-ad6a-8ba7d136abf2	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	SPL version
0135-0537-01	PANADOL	15 mL in 1 BOTTLE	SUSPENSION	15	14
0135-0537-01	PANADOL	1 in 1 CARTON	SUSPENSION	1	14
0135-0537-02	PANADOL	54.7 mL in 1 BOTTLE	SUSPENSION	54.7	14
0135-0537-02	PANADOL	1 in 1 CARTON	SUSPENSION	1	14
0135-0537-03	PANADOL	1 in 1 CARTON	SUSPENSION	1	14
0135-0537-03	PANADOL	118 mL in 1 BOTTLE	SUSPENSION	118	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0537-03	ML - Milliliter	0135-0537	4d37b28e-b7a6-4ed1-a89f-c37b76e475d4	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]	8
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0537	PANADOL (ACETAMINOPHEN) SUSPENSION [HALEON US HOLDINGS LLC]	14	Current NDC, Legacy NDC, 6 package rows	20240207_e1799765-c247-42b4-ad6a-8ba7d136abf2.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 24 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menstrual Relief Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	United Natural Foods, Inc. dba UNFI	807598ef-9f03-48df-b076-3ee95ef4b06c	2026-01-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength, Non-Aspirin	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	1fb5e871-45fd-46fe-bf73-5192f8316e8e	2026-01-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Valu Merchandisers Company	0005aafa-08f8-4990-a54d-cc097195708f	2026-01-02	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	Walmart Inc.	152bb455-da5b-ae13-e063-6394a90acab0	2026-01-01	Warnings	Exact identifier application number: M013
Dr. Cocoa for Children Pain and Fever	ACETAMINOPHEN	Infirst Healthcare Inc.	486ea294-6d18-a907-e063-6294a90ad284	2026-01-01	Warnings	Exact identifier application number: M013
ED APAP	ACETAMINOPHEN	EDWARDS PHARMACEUTICALS, INC.	f76d5fff-ebea-40f9-aad3-4064a0c863f0	2025-12-31	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEF	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	99ec63ef-aa28-c2fb-e053-2a95a90a9f6d	2025-12-31	Warnings	Exact identifier application number: M013
Puregen Labs Acetaminophen	ACETAMINOPHEN	Advanced Rx LLC	474580af-f6b0-e440-e063-6394a90aaada	2025-12-31	Warnings	Exact identifier application number: M013
Liquid Acetaminophen	ACETAMINOPHEN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	2025-12-31	Warnings	Exact identifier application number: M013
Llorens Care Children Acetaminophen	ACETAMINOPHEN	Llorens Pharmaceutical International Division, Inc.	2a46d7d2-293b-5024-e063-6294a90a31aa	2025-12-31	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)	Walgreens	3a801457-c5d0-b134-e063-6294a90ac5cb	2025-12-31	Warnings	Exact identifier application number: M013
Daytime and Nighttime Severe Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Genexa Inc.	190c7eaf-dcd4-d314-e063-6294a90a6f33	2025-12-30	Warnings	Exact identifier application number: M013
BioElectro Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Genomma Lab USA	683a0fba-921c-48e7-a391-180c04f0d1c4	2025-12-30	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	0181af13-da32-4431-be39-c31fdfac9202	2025-12-29	Warnings	Exact identifier application number: M013
Gemma Cut the Cramp	ASPIRIN, CAFFEINE	Rally Labs LLC	16c9a296-077a-8e12-e063-6294a90a1b8b	2025-12-29	Warnings	Exact identifier application number: M013
Blowfish	ASPIRIN, CAFFEINE	Rally Labs LLC	0d3798bc-04ef-584e-821b-7aa76036b7d1	2025-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	ad29a37f-39a2-5c84-e053-2995a90a2f39	2025-12-29	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Pioneer Life Sciences, LLC	ac9efd62-8fee-b777-e053-2995a90a3783	2025-12-29	Warnings	Exact identifier application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry	ACETAMINOPHEN	Puro Pharma Inc.	a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009	2025-12-27	Warnings	Exact identifier application number: M013
Cystex PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Clarion Brands, LLC	9668a2ca-729e-4172-80b5-33e6c5175ba4	2025-12-27	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
0135-0537-01	00135053701	1 BOTTLE in 1 CARTON (0135-0537-01) / 15 mL in 1 BOTTLE	1 bottle	2012-10-15	0000-00-00	No	No	Current
0135-0537-02	00135053702	54.7 mL in 1 BOTTLE	54.7 ml					Historical
0135-0537-03	00135053703	1 BOTTLE in 1 CARTON (0135-0537-03) / 118 mL in 1 BOTTLE	1 bottle	2012-10-15	0000-00-00	No	No	Current