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

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 1 of 85 · 1,687 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tension Headache Aspirin-Free	ACETAMINOPHEN, CAFFEINE	Rite Aid Corporation	093a7c26-f2b1-4416-b193-81133d247d2e	2026-08-06	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Kroger Company	bc17b2e5-4828-6a2e-e053-2995a90a8c63	2026-08-05	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	997b9551-c222-4a9c-8ba1-09a5f97495fa	2026-08-05	Warnings	Exact identifier application number: M013
Mantra Pain Gel raspberry	ACETAMINOPHEN	MOREMED INC.	7c8bdf49-a6d2-4e42-b006-375f103fd0ac	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	d2d2846d-4e0b-4d42-b300-60dd3b2cca1b	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	960f5676-d8c5-470b-a663-4b8d152339b4	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	a60f6439-2033-4bd2-b78c-6c083414a12b	2026-08-05	Warnings	Exact identifier application number: M013
pain relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	HARRIS TEETER	0afb6181-d0b1-4845-8230-faabf1b997dc	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	8a3e3439-90ae-4fc9-8ff2-44b8363fa338	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Harris Teeter	50e7b939-e0eb-44ea-82ea-034e844e2c29	2026-08-05	Warnings	Exact identifier application number: M013
pain relief aspirin Low Dose	ASPIRIN	Rite Aid Corporation	df7835c9-f10f-40c6-8955-61423d94b677	2026-08-05	Warnings	Exact identifier application number: M013
childrens acetaminophen	ACETAMINOPHEN	WinCo Foods, LLC	4749a843-9c93-4edd-9b5f-a1e32666544e	2026-08-04	Warnings	Exact identifier application number: M013
SurviveX Travel Med MOD	CONVENIENCE KIT	Intent Brands LLC	522da86b-cfd7-dd20-e063-6394a90a51c6	2026-08-04	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever mini softgels	ACETAMINOPHEN 500 MG	Shield Pharmaceuticals Corp	0ebb1902-6f8a-4bfb-9f2e-839d43bfca37	2026-08-04	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Better Living Brands, LLC	743af02c-c762-42f5-8e01-2f62da15e04e	2026-08-04	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	9aea8aae-8702-4c93-8b07-69cd252f44d6	2026-08-03	Warnings	Exact identifier application number: M013
Pain Relief Acetaminophen 325 mg	ACETAMINOPHEN	NUVICARE LLC	49a59b79-b8b4-4bf5-a403-0a14751efc55	2026-08-03	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	d4e98f8e-f24c-4bdd-b750-fa4f877fb621	2026-07-31	Warnings	Exact identifier application number: M013
KinderFarms Childrens Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	4f86419a-b940-a9c6-e063-6394a90a6a2b	2026-07-30	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	Family Dollar Stores, LLC	53f7a9c8-f40e-19b2-e063-6394a90a8695	2026-07-29	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