Acetaminophen

Product NDC: 0121-1047
11-digit product format: 001211047
Labeler code: 0121
Product ID: 0121-1047_ba8d56c1-521e-490b-a83e-ebfa2d51bd8b
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: 2025-12-09
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: Acetaminophen
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 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
fac4e0c6-684f-45a1-99f2-de4de4017cc8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-1047-00	Acetaminophen	10 in 1 TRAY	SOLUTION	10	3
0121-1047-00	Acetaminophen	10 in 1 CASE	SOLUTION	10	3
0121-1047-05	Acetaminophen	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1047-00	ML - Milliliter	0121-1047	010e68ff-88f2-49e0-a6ec-8d3f015bd9ae	1	2026-01-08
0121-1047-05	ML - Milliliter	0121-1047	93277862-3358-4c4c-baea-8af76ea16da3	1	2026-01-08

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 78 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regular Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	f06fe167-8a16-14d9-e053-2a95a90a1a0f	2023-10-17	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	BLESSINGS INTERNATIONAL	ee8ba190-2c42-7ca2-e053-2a95a90a01a0	2023-10-17	Warnings	Exact identifier application number: M013
Aphen	ACETAMINOPHEN	Asclemed USA, Inc.	fe3c0a2b-316b-4620-b6bc-378dbaf7ed57	2023-10-16	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreens	b4b06d32-6a09-4c43-980b-377b617ba739	2023-10-09	Warnings	Exact identifier application number: M013
FLO PMS Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	O Positiv, Inc.	cce62d9f-adb1-4473-8258-910dff6b1378	2023-10-09	Warnings	Exact identifier application number: M013
childrens mapap	ACETAMINOPHEN	Proficient Rx LP	88c4183a-3032-46de-bf18-f700055f617b	2023-10-01	Warnings	Exact identifier application number: M013
Tri-Buffered Aspirin	ASPIRIN	Proficient Rx LP	640c3311-2abf-40b2-82b9-9fe4d8c1cf1d	2023-10-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY, INC	852e70e2-7279-6f33-e053-2991aa0a8676	2023-08-28	Warnings	Exact identifier application number: M013
Children Pain Relief	CHILDREN PAIN RELIEF	Allegiant Health	44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096	2023-07-17	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Better Living Brands LLC	4a76e898-3204-4f77-bc67-c19f5fe829f3	2023-07-05	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Lodaat LLC	04017bc9-602a-4204-96a9-b7f9713155f6	2023-01-31	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	WALGREENS	d71a22e8-9e39-a672-e053-2a95a90a1403	2022-07-08	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	PAIN RELIEF	Allegiant Health	d41d2319-8eed-4df9-813c-313497ceb8b4	2021-11-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	PAIN RELIEF PM	Allegiant Health	4c9969be-a01f-4ca4-800a-e404229ce28b	2021-11-23	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	9d348550-060b-410f-8c1e-8f43d00b860e	2021-11-22	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	847fd2f8-2e32-4ef2-a793-b902045110f1	2021-11-19	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Allegiant Health	d6c7c8c9-b997-4acc-a066-133bfb1239cb	2021-11-02	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Dr. Wayne's	eacbdf9e-5642-4986-a03c-b0812d28265d	2021-11-02	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	d9abe780-7e58-43d8-848f-c6c8893aea2e	2021-10-14	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500MG	Allegiant Health	0f72be92-fac0-4be4-87a3-3f20f0f01db5	2021-05-17	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	fac4e0c6-684f-45a1-99f2-de4de4017cc8	3
307675	acetaminophen 32 MG/ML Oral Solution	SCD	fac4e0c6-684f-45a1-99f2-de4de4017cc8	3
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	fac4e0c6-684f-45a1-99f2-de4de4017cc8	3
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	fac4e0c6-684f-45a1-99f2-de4de4017cc8	3
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	fac4e0c6-684f-45a1-99f2-de4de4017cc8	3
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	fac4e0c6-684f-45a1-99f2-de4de4017cc8	3
307675	APAP 32 MG/ML Oral Solution	SY	fac4e0c6-684f-45a1-99f2-de4de4017cc8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-1047-00	00121104700	10 TRAY in 1 CASE (0121-1047-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1047-05)	10 tray	2025-12-09	No	No	Current
0121-1047-05	00121104705	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Oral Solution USP Alcohol Free/Dye Free/Sugar Free Grape Flavored	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2025-12-11	HUMAN OTC DRUG LABEL	3