Acetaminophen

Product NDC: 0121-1971
11-digit product format: 001211971
Labeler code: 0121
Product ID: 0121-1971_1f8166c0-62db-10f8-e063-6394a90a86cf
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-08-01
Substance: ACETAMINOPHEN
Active strength: 650 mg/20.3mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0121-1971		D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0121-1971	0121-1971-00	D	Discontinued by firm		excluded / ndc_excluded.zip	`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: Acetaminophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/20.3mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307675	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
6ec12573-03d6-40c1-9945-d345b401e062	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-1971-00	Acetaminophen	10 in 1 TRAY	SOLUTION	10	15
0121-1971-00	Acetaminophen	10 in 1 CASE	SOLUTION	10	15
0121-1971-21	Acetaminophen	20.3 mL in 1 CUP, UNIT-DOSE	SOLUTION	20.3	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1971-00	ML - Milliliter	0121-1971	0810fe27-830b-41ad-af96-53d88d40b4a8	1	2017-03-06
0121-1971-21	ML - Milliliter	0121-1971	91884f5f-dfff-4883-ad2e-d5461d422e40	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1971	ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	15	Current NDC, Legacy NDC, 3 package rows	20240814_6ec12573-03d6-40c1-9945-d345b401e062.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 71 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	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
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	6ec12573-03d6-40c1-9945-d345b401e062	15
307675	acetaminophen 32 MG/ML Oral Solution	SCD	6ec12573-03d6-40c1-9945-d345b401e062	15
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	6ec12573-03d6-40c1-9945-d345b401e062	15
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	6ec12573-03d6-40c1-9945-d345b401e062	15
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	6ec12573-03d6-40c1-9945-d345b401e062	15
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	6ec12573-03d6-40c1-9945-d345b401e062	15
307675	APAP 32 MG/ML Oral Solution	SY	6ec12573-03d6-40c1-9945-d345b401e062	15
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	e13656eb-513e-411e-bdae-35ff1ba7cfc1	9
307675	acetaminophen 32 MG/ML Oral Solution	SCD	e13656eb-513e-411e-bdae-35ff1ba7cfc1	9
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	e13656eb-513e-411e-bdae-35ff1ba7cfc1	9
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	e13656eb-513e-411e-bdae-35ff1ba7cfc1	9
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	e13656eb-513e-411e-bdae-35ff1ba7cfc1	9
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	e13656eb-513e-411e-bdae-35ff1ba7cfc1	9
307675	APAP 32 MG/ML Oral Solution	SY	e13656eb-513e-411e-bdae-35ff1ba7cfc1	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-1971-00	00121197100	10 TRAY in 1 CASE (0121-1971-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0121-1971-21)	10 tray	2007-08-01	0000-00-00	No	No	Current
0121-1971-21	00121197121	20.3 mL in 1 CUP, UNIT-DOSE	20.3 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Oral Solution USP Alcohol Free	Cardinal Health 107, LLC	2026-04-13	HUMAN OTC DRUG LABEL	9
Acetaminophen Oral Solution USP Alcohol Free	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-08-12	HUMAN OTC DRUG LABEL	15