PANADOL

Product NDC: 0135-0609
Requested package NDC: 0135-0609-01
11-digit product format: 001350609
Labeler code: 0135
Product ID: 0135-0609_10c10ae1-2b66-f708-e063-6394a90a0fca
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-03-15
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
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: Extra Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198440	Internal RxNorm lookup
200977	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
b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
0135-0609-01	Drug Facts
0135-0609-02	Drug Facts
0135-0609-03	Drug Facts
0135-0609-04	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0609-01	PANADOLExtra Strength	24 in 1 BOTTLE	TABLET, FILM COATED	24	7
0135-0609-01	PANADOLExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	7
0135-0609-02	PANADOLExtra Strength	50 in 1 BOTTLE	TABLET, FILM COATED	50	7
0135-0609-02	PANADOLExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	7
0135-0609-03	PANADOLExtra Strength	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
0135-0609-03	PANADOLExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	7
0135-0609-04	PANADOLExtra Strength	50 in 1 CARTON	TABLET, FILM COATED	50	7
0135-0609-05	PANADOLExtra Strength	2 in 1 PACKET	TABLET, FILM COATED	2	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0609-01	EA - Each	0135-0609	fe1f0735-9843-4fe3-bb42-0a2256c3b2c6	1	2022-12-07
0135-0609-02	EA - Each	0135-0609	2e35bea5-0a22-4410-ac97-e2465812c2d8	1	2022-12-07
0135-0609-03	EA - Each	0135-0609	a22d623d-3cc7-4af6-a98a-fbe4fceff390	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0609	PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC]	7	Current NDC, Legacy NDC, 8 package rows	20240207_b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b.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 70 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain Relief Dye-Free	ACTEAMINOPHEN	WinCo Foods, LLC	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	2024-04-11	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d086f-7be1-5072-e063-6394a90a11e6	2024-04-10	Warnings	Exact identifier application number: M013
Dye Free Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d88d8-56ff-9e9d-e063-6394a90a015c	2024-04-09	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	H E B	4d572228-3141-4539-9c3d-2fd06e94eee3	2024-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	1b5ff867-5442-4cf8-bd1e-530093cc88f8	2024-04-05	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	0faa3592-4d56-4645-9a0e-066e0bdfebb6	2024-04-05	Warnings	Exact identifier application number: M013
Pain Relief Childrens Dye Free	ACETAMINOPHEN	H E B	3f9beeeb-5e27-4b81-a647-20e65f0e9fc9	2024-04-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	H E B	edb321dd-e5cb-4031-a8a8-efce9e86fe16	2024-04-03	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	H E B	a0c0277e-50aa-4328-8f93-ab20c6176b2b	2024-04-03	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Bryant Ranch Prepack	bda805ab-7f37-405d-a144-4e06ad9a29a1	2024-04-03	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	650cb15e-c448-4df3-b0f8-4398be05d841	2024-03-27	Warnings	Exact identifier application number: M013
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7
200977	Panadol Extra Strength 500 MG Oral Tablet	PSN	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7
200977	acetaminophen 500 MG Oral Tablet [Panadol]	SBD	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7
198440	acetaminophen 500 MG Oral Tablet	SCD	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7
198440	APAP 500 MG Oral Tablet	SY	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7
200977	APAP 500 MG Oral Tablet [Panadol]	SY	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7
200977	Panadol 500 MG Oral Tablet	SY	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7
200977	Panadol Extra Strength 500 MG Oral Tablet	SY	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0609-01	00135060901	1 BOTTLE in 1 CARTON (0135-0609-01) / 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2017-03-15	0000-00-00	No	No	Current