Aspirin Low Dose Chewable Orange

Product NDC: 0904-6794
11-digit product format: 009046794
Labeler code: 0904
Product ID: 0904-6794_f2922418-7d2c-4a41-b28a-41769521b297
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: MAJOR PHARMACEUTICALS
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-09-27
Substance: ASPIRIN
Active strength: 81 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-6794	0904-6794-30	D	Discontinued by firm		2026-10-21

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: Aspirin Low Dose Chewable Orange
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASPIRIN	81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R16CO5Y76E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
318272	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
fb3a8e38-e991-49c9-93dc-1d29c0a97ba3	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
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-6794-30	Aspirin Low Dose Chewable Orange	300 in 1 CARTON	TABLET, CHEWABLE	300	7
0904-6794-30	Aspirin Low Dose Chewable Orange	1 in 1 BLISTER PACK	TABLET, CHEWABLE	1	7
0904-6794-80	Aspirin Low Dose Chewable Orange	1000 in 1 PACKAGE	TABLET, CHEWABLE	1000	7
0904-6794-89	Aspirin Low Dose Chewable Orange	90 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6794-30	EA - Each	0904-6794	0b6b3501-8a59-4d48-864f-25efe4b44759	1	2023-04-07
0904-6794-80	EA - Each	0904-6794	78376407-1c58-42be-9458-6e0c62198068	1	2018-11-06
0904-6794-89	EA - Each	0904-6794	b50d3dc8-f0d6-49f7-ac05-baa38562ec1d	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6794	ASPIRIN LOW DOSE CHEWABLE ORANGE (ASPIRIN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 4 package rows	20241226_fb3a8e38-e991-49c9-93dc-1d29c0a97ba3.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 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	691b754c-bafc-47e2-a322-cf56245c01f6	2024-03-14	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	fdc80b2a-d7c1-4b3d-9a9b-28182c6320de	2024-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2cde052d-22a4-470f-8d6a-7c17061b8ac8	2024-03-14	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
318272	aspirin 81 MG Chewable Tablet	PSN	dbdc7cae-b2ed-4504-83a0-0a41b4e45003	10
318272	aspirin 81 MG Chewable Tablet	SCD	dbdc7cae-b2ed-4504-83a0-0a41b4e45003	10
318272	ASA 81 MG Chewable Tablet	SY	dbdc7cae-b2ed-4504-83a0-0a41b4e45003	10
318272	aspirin 81 MG Chewable Tablet	PSN	fb3a8e38-e991-49c9-93dc-1d29c0a97ba3	7
318272	aspirin 81 MG Chewable Tablet	SCD	fb3a8e38-e991-49c9-93dc-1d29c0a97ba3	7
318272	ASA 81 MG Chewable Tablet	SY	fb3a8e38-e991-49c9-93dc-1d29c0a97ba3	7
318272	aspirin 81 MG Chewable Tablet	PSN	a0d8ee59-1ce0-4ddd-a90c-54adb512540c	4
318272	aspirin 81 MG Chewable Tablet	SCD	a0d8ee59-1ce0-4ddd-a90c-54adb512540c	4
318272	ASA 81 MG Chewable Tablet	SY	a0d8ee59-1ce0-4ddd-a90c-54adb512540c	4
318272	aspirin 81 MG Chewable Tablet	PSN	4ba6eed3-004a-4576-b7f7-685fae49cf6a	3
318272	aspirin 81 MG Chewable Tablet	PSN	21042405-9c7e-4a72-8984-27ad3433eaa9	3
318272	aspirin 81 MG Chewable Tablet	SCD	4ba6eed3-004a-4576-b7f7-685fae49cf6a	3
318272	aspirin 81 MG Chewable Tablet	SCD	21042405-9c7e-4a72-8984-27ad3433eaa9	3
318272	ASA 81 MG Chewable Tablet	SY	21042405-9c7e-4a72-8984-27ad3433eaa9	3
318272	ASA 81 MG Chewable Tablet	SY	4ba6eed3-004a-4576-b7f7-685fae49cf6a	3
318272	aspirin 81 MG Chewable Tablet	PSN	13e621dc-b2b4-98fd-e063-6394a90acc75	1
318272	aspirin 81 MG Chewable Tablet	PSN	9e08b91c-b067-4ccd-ae0d-01f48f992f20	1
318272	aspirin 81 MG Chewable Tablet	SCD	9e08b91c-b067-4ccd-ae0d-01f48f992f20	1
318272	aspirin 81 MG Chewable Tablet	SCD	13e621dc-b2b4-98fd-e063-6394a90acc75	1
318272	ASA 81 MG Chewable Tablet	SY	9e08b91c-b067-4ccd-ae0d-01f48f992f20	1
318272	ASA 81 MG Chewable Tablet	SY	13e621dc-b2b4-98fd-e063-6394a90acc75	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6794-30	00904679430	300 in 1 CARTON					Historical
0904-6794-80	00904679480	1000 TABLET, CHEWABLE in 1 PACKAGE (0904-6794-80)	2018-09-27	0000-00-00	No	No	Current
0904-6794-89	00904679489	90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0904-6794-89)	2018-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Major Pharmaceuticals	2026-05-04	HUMAN OTC DRUG LABEL	3
Drug Facts	Cardinal Health 107, LLC	2026-04-10	HUMAN OTC DRUG LABEL	3
Drug Facts	MAJOR PHARMACEUTICALS \| Pharbest Pharmaceuticals, Inc.	2026-03-05	HUMAN OTC DRUG LABEL	7
ASPIRIN LOW DOSE CHEW	ATLANTIC BIOLOGICALS CORP.	2025-06-24	HUMAN OTC DRUG LABEL	4
Aspirin Chewable Tabs 8257	NCS HealthCare of KY, LLC dba Vangard Labs	2025-01-24	HUMAN OTC DRUG LABEL	10
Drug Facts	Proficient Rx LP	2024-10-01	HUMAN OTC DRUG LABEL	1
ASPIRIN - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2024-03-17	HUMAN OTC DRUG LABEL	1
Drug Facts	A-S Medication Solutions	2024-03-11	HUMAN OTC DRUG LABEL	4
Drug Facts	A-S Medication Solutions	2024-03-11	HUMAN OTC DRUG LABEL	2
Drug Facts	REMEDYREPACK INC.	2022-04-04	HUMAN OTC DRUG LABEL	5