Adult Low Dose Aspirin Enteric Coated

Product NDC: 16103-351
11-digit product format: 161030351
Labeler code: 16103
Product ID: 16103-351_45b929af-8d23-4414-9c47-fe92e6c7e9af
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin 81mg
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-20
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-351-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-351-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-351-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-351-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-351-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-351-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-351-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-351-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-351-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-351-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-351-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-351-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-351-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-351-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-351-16	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-351-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-351-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-351-16	`1332a3947898…`	`d4bfe170f9cd…`

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: Adult Low Dose Aspirin Enteric Coated
Listing expiration: 2026-12-31

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
308416	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
45e5bae9-22a7-4699-85ea-5b922af6b96d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16103-351-09	2024-12-31	Drug Facts
16103-351-11	2024-12-31	Drug Facts
16103-351-16	2024-12-31	Drug Facts
16103-351-09	2023-01-30	Drug Facts
16103-351-11	2023-01-30	Drug Facts
16103-351-16	2023-01-30	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16103-351-09	Adult Low Dose Aspirin Enteric Coated	120 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	120	4
16103-351-11	Adult Low Dose Aspirin Enteric Coated	1000 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	1000	4
16103-351-16	Adult Low Dose Aspirin Enteric Coated	300 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	300	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-351	ADULT LOW DOSE ASPIRIN ENTERIC COATED (ASPIRIN 81MG) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20250101_45e5bae9-22a7-4699-85ea-5b922af6b96d.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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Rapid Relief	ACETAMINOPHEN	Haleon US Holdings LLC	3a36b7ca-396e-cfd8-e063-6294a90a76ab	2026-02-22	Warnings	Exact identifier application number: M013
CHILDRENS Acetaminophen	CHILDRENS ACETAMINOPHEN	Kesin Pharma Corporation	4af5b025-1fd7-e825-e063-6294a90aa005	2026-02-16	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	4a121a53-dbae-05c7-e063-6294a90aed89	2026-02-13	Warnings	Exact identifier application number: M013
MAX relief junior Grape	CHILDRENS ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	562d7901-44d6-4d9b-be8b-a8d468a22c43	2026-02-13	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	020fa486-31f0-4e0c-84d3-5b3aaded1eeb	2026-02-13	Warnings	Exact identifier application number: M013
ASPIRIN Low Strength	ASPIRIN	CVS Pharmacy	6e1c1129-562b-4a8a-ac37-db3cb2a82735	2026-02-11	Warnings	Exact identifier application number: M013
CVS Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	3dd21aaf-13b2-9e81-e063-6294a90afaec	2026-02-11	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE	CVS Pharmacy	ddd78b28-6e10-4708-bed1-8aea087b3d82	2026-02-11	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Topco Associates, LLC	2e31fe65-5f50-455b-99fa-c72879f43545	2026-02-10	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	Amerisource Bergen	9ea8bb1f-1924-4430-98bd-f2674d0da748	2026-02-09	Warnings	Exact identifier application number: M013
Acetaminophen , Caffeine and pyrilamine maleate	ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE	Softgel Healthcare Pvt Ltd	4a61313e-1b48-29df-e063-6394a90a27f0	2026-02-09	Warnings	Exact identifier application number: M013
good sense aspirin	ASPIRIN	L. Perrigo Company	e9fddbc1-11fe-4cf6-8794-1650fa1b32ae	2026-02-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	2d375ec9-a528-4048-a15b-652fa20e74a7	2026-02-06	Warnings	Exact identifier application number: M013
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Sportpharm LLC	d3379569-7949-4f78-b634-5d4178b21ea4	2026-02-06	Warnings	Exact identifier application number: M013
Buffered Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	e5f68c1a-21f3-45a1-861f-229a95b3721c	2026-02-06	Warnings	Exact identifier application number: M013
pain relief extra strength	ACETAMINOPHEN	HyVee Inc	1e707628-08b1-4c72-b71c-2b4ae96071f2	2026-02-06	Warnings	Exact identifier application number: M013
CareOne Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	American Sales Company	2d2ded37-f241-4976-886d-5c038a85bfe1	2026-02-05	Warnings	Exact identifier application number: M013
Dolex Fem	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Pharmadel LLC	b1cab10b-19f1-f5d5-e053-2995a90a4d5f	2026-02-05	Warnings	Exact identifier application number: M013
Alka-Seltzer Extra Strength Pain Relief	ANHYDROUS CITRIC ACID, ASPIRIN	Bayer HealthCare LLC.	4a16b6e5-f0c6-e3a4-e063-6294a90a85ad	2026-02-05	Warnings	Exact identifier application number: M013
Pain Relief childrens	ACETAMINOPHEN	CVS PHARMACY	b8ab85a6-3eab-4ef4-a13d-5ac300480f63	2026-02-03	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
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	45e5bae9-22a7-4699-85ea-5b922af6b96d	4
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	45e5bae9-22a7-4699-85ea-5b922af6b96d	4
308416	ASA 81 MG Delayed Release Oral Tablet	SY	45e5bae9-22a7-4699-85ea-5b922af6b96d	4
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	45e5bae9-22a7-4699-85ea-5b922af6b96d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-351-09	16103035109	120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-351-09)	2019-02-20	0000-00-00	No	No	Current
16103-351-11	16103035111	1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-351-11)	2019-02-20	0000-00-00	No	No	Current
16103-351-16	16103035116	300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-351-16)	2019-02-20	0000-00-00	No	No	Current