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 55 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	667418fc-a3ab-cbc7-e053-2a91aa0a2023	2024-11-13	Warnings	Exact identifier application number: M013
Up and Up Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Target Corporation	a72eef45-b985-638a-e053-2995a90aa20a	2024-11-13	Warnings	Exact identifier application number: M013
Signature Care Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Safeway, Inc	6e120024-475a-73af-e053-2a91aa0a42a6	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier application number: M013
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier application number: M013
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier application number: M013
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier application number: M013
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	Warnings	Exact identifier application number: M013
Publix Fast Relief Effervescent	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Publix Super Markets Inc.	73051f16-2569-7394-e053-2991aa0a5359	2024-11-13	Warnings	Exact identifier application number: M013
Quality Choice Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	70d265de-ff94-e0e4-e053-2a91aa0a962a	2024-11-13	Warnings	Exact identifier application number: M013
Quality Choice Extra Strength Effervescent Antacid and Pain Relief	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	9f7d0c96-a561-a8a0-e053-2995a90a250b	2024-11-13	Warnings	Exact identifier application number: M013
WinCo Foods Effervescent Antacid and Pain Relief	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET	WinCo Foods, LLC	0c8a755a-089f-477f-97e9-0dd6fdfbe99d	2024-11-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Kroger Company	8fb19444-f0e0-4d26-81e8-6a4b835056d8	2024-11-12	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	59d01f72-4575-48e2-b914-b6a6456ca7d2	2024-11-11	Warnings	Exact identifier application number: M013
pain and fever	ACETAMINOPHEN	Kroger Company	d181560c-1c39-4f2e-8a17-996224ca040f	2024-11-09	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