Acetaminophen

Product NDC: 0121-2823
11-digit product format: 001212823
Labeler code: 0121
Product ID: 0121-2823_bbd6f65a-a6ec-4c17-935c-ed743c45e2c8
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-09-03
Substance: ACETAMINOPHEN
Active strength: 650 mg/20.3mL
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	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
307668	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
caf5daea-409e-5dd2-e053-2995a90acb12	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-2823-21	Acetaminophen	20.3 mL in 1 CUP, UNIT-DOSE	SUSPENSION	20.3	5
0121-2823-94	Acetaminophen	10 in 1 TRAY	SUSPENSION	10	5
0121-2823-94	Acetaminophen	3 in 1 CASE	SUSPENSION	3	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-2823-21	ML - Milliliter	0121-2823	718f60b6-0027-4acc-9dfd-b7d15553ffbb	1	2022-01-06
0121-2823-94	ML - Milliliter	0121-2823	fcc3545e-3a08-4bc7-a690-dfb8483128be	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-2823	ACETAMINOPHEN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]	4	Current NDC, Legacy NDC, 3 package rows	20241114_caf5daea-409e-5dd2-e053-2995a90acb12.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 59 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e21e90e8-b9f1-1133-e053-2995a90a664b	2024-10-22	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Publix Super Markets Inc	c51dae48-aa49-4926-b04a-0da264e08dfa	2024-10-22	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	b96a2280-ec4f-7c61-e053-2995a90a18bb	2024-10-22	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	f17a18b0-a7c2-4c64-868c-460cf34e1f7d	2024-10-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	0863aeaa-15ec-4c67-ba79-4dad54555bd2	2024-10-21	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	American Health Packaging	3c0175a0-175b-48b8-9192-3f869690c0f2	2024-10-21	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	American Health Packaging	0d6553bd-3e18-4624-a83a-899bcafb3272	2024-10-21	Warnings	Exact identifier application number: M013
Childrens Acetaminophen Oral Suspension	ACETAMINOPHEN	American Health Packaging	8231dd91-e9e6-4350-a485-fa95d65a6d25	2024-10-21	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	cf63c372-acdd-6e6e-e053-2995a90a1662	2024-10-21	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	L. Perrigo Company	8b56bfc0-2253-458d-99a6-0b0f9ae0ba50	2024-10-21	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	GOODSENSE	662a2bc6-9507-465c-b467-7ae1b2e1dedc	2024-10-18	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	GoodSense	da4339c0-1822-41d8-8c20-214c379a5aa7	2024-10-18	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	GoodSense	8972d95a-51da-40b5-8ef1-9dfed220d7eb	2024-10-18	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	AmeriSource Bergen	d571f520-a56e-4f7f-9214-d89197f742b6	2024-10-18	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	6b4b7f72-dac8-4b59-a58c-7c59d4b1ef32	2024-10-18	Warnings	Exact identifier application number: M013
dg health pain relief	ACETAMINOPHEN	Dolgencorp Inc	2e1470f5-e88f-4d1d-a308-170f7080387e	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	146c735b-5081-4de4-9025-d939d560bbba	2024-10-17	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	DISCOUNT DRUG MART	c8483d64-874c-3056-e053-2995a90ad8aa	2024-10-17	Warnings	Exact identifier application number: M013
Adult Chewable Aspirin	ASPIRIN	DISCOUNT DRUG MART	c8484998-e0e1-ffce-e053-2995a90aa7de	2024-10-17	Warnings	Exact identifier application number: M013
Adult Low Strength Aspirin	ASPIRIN	DISCOUNT DRUG MART	9196e6de-432a-4f1c-b09b-226e4717c87c	2024-10-17	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
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	caf5daea-409e-5dd2-e053-2995a90acb12	5
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	caf5daea-409e-5dd2-e053-2995a90acb12	5
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	caf5daea-409e-5dd2-e053-2995a90acb12	5
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	caf5daea-409e-5dd2-e053-2995a90acb12	5
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	caf5daea-409e-5dd2-e053-2995a90acb12	5
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	caf5daea-409e-5dd2-e053-2995a90acb12	5
307668	APAP 32 MG/ML Oral Suspension	SY	caf5daea-409e-5dd2-e053-2995a90acb12	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-2823-21	00121282321	20.3 mL in 1 CUP, UNIT-DOSE	20.3 ml					Historical
0121-2823-94	00121282394	3 TRAY in 1 CASE (0121-2823-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0121-2823-21)	3 tray	2021-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Oral Suspension	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2025-08-18	HUMAN OTC DRUG LABEL	5