Chewable Acetaminophen

Product NDC: 70000-0309
11-digit product format: 700000309
Labeler code: 70000
Product ID: 70000-0309_d856ac50-a8ec-430c-b137-1791002e28c8
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Cardinal Health 110, LLC. DBA Leader
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-01-28
Substance: ACETAMINOPHEN
Active strength: 160 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Chewable Acetaminophen
Brand name suffix: Childrens
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313820	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
8a18565c-b84e-43f8-8e96-e1dbcc39f08b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0309-1	Chewable AcetaminophenChildrens	24 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	24		12
70000-0309-1	Chewable AcetaminophenChildrens	1 in 1 CARTON	TABLET, CHEWABLE	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0309-1	EA - Each	70000-0309	106fca47-a1f5-4572-9822-c4ca5e808459	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0309	CHEWABLE ACETAMINOPHEN CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER]	11	Current NDC, Legacy NDC, 2 package rows	20250424_8a18565c-b84e-43f8-8e96-e1dbcc39f08b.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 53 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6fee238-0b6f-cb84-e053-2995a90a361b	2024-12-05	Warnings	Exact identifier application number: M013
Menstrual Complete Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	L.N.K. International, Inc.	379ef03c-3b6a-40c3-b736-99f0537d26c8	2024-12-05	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Marc Glassman, Inc.	43bf297f-2832-424f-a013-4bfa1d6c03e6	2024-12-04	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	5a68ab98-720c-479a-a60a-4e594add6c09	2024-12-04	Warnings	Exact identifier application number: M013
HEB Effervescent Pain Relief	ASPIRIN	H. E. BUTT GROCERY COMPANY	03876c71-60ec-3280-e063-6294a90a62dc	2024-12-03	Warnings	Exact identifier application number: M013
Migrafein FORTE	ACETAMINOPHEN, CAFFEINE	OPMX LLC	028875c9-4129-ce2c-e063-6294a90a26cc	2024-12-03	Warnings	Exact identifier application number: M013
Neo-Lubrina Fuerte	ACETAMINOPHEN, CAFFEINE	OPMX LLC	0288a327-fd4b-1991-e063-6294a90ace50	2024-12-03	Warnings	Exact identifier application number: M013
CAFIZETAMOL FORTE	ACETAMINOPHEN, CAFFEINE	OPMX LLC	028771d3-a514-f7a5-e063-6394a90ac4f3	2024-12-03	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	048c4b03-1cf4-b724-e063-6294a90a1cad	2024-12-03	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	TopCo Associates LLC	ecd6df7e-e7e2-446b-85ef-25971281fe31	2024-12-03	Warnings	Exact identifier application number: M013
Market Basket Effervescent Pain Relief	ASPIRIN	DEMOULAS SUPER MARKETS, INC.	08133bf0-3c8f-e4d0-e063-6294a90af79a	2024-12-03	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	WinCo Foods, LLC	4359da13-e851-440b-91b9-6b544bff20d2	2024-12-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	WinCo Foods, LLC	5b3e8a78-5357-42ad-811e-b2578b25dc7b	2024-12-03	Warnings	Exact identifier application number: M013
Low Strength Chewable Aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	cc77b9d1-7874-4ce8-a763-3a0e1c2891de	2024-12-03	Warnings	Exact identifier application number: M013
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	L. Perrigo Company	c6b79501-d08b-4430-9545-70da5f545975	2024-12-03	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Chain Drug Marketing Association	0e3be5f4-bc1b-4b44-a86a-ace89f6ee592	2024-12-02	Warnings	Exact identifier application number: M013
St. Joseph Chewable Low Dose Aspirin	ASPIRIN	Foundation Consumer Healthcare LLC	248cd302-e380-4837-bdae-9df620b67e8a	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	2d98e390-4f2a-41cc-b307-3d2f6a3700dd	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	409b5fcd-5880-4dda-85d8-26aeceb4f8ab	2024-12-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	c0c31523-c4c5-43c2-8d72-4d1456c720e9	2024-12-02	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
313820	acetaminophen 160 MG Chewable Tablet	PSN	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	12
313820	acetaminophen 160 MG Chewable Tablet	SCD	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	12
313820	APAP 160 MG Chewable Tablet	SY	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0309-1	70000030901	1 BOTTLE, PLASTIC in 1 CARTON (70000-0309-1) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC	2005-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader 44-449	Cardinal Health 110, LLC. DBA Leader \| LNK International, Inc.	2026-04-02	HUMAN OTC DRUG LABEL	12