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 19 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin Regular Strength	ASPIRIN	Rite Aid Corporation	879e2258-f61b-47ad-a4b1-7d1e78823570	2026-03-05	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	ARMY AND AIR FORCE EXCHANGE SERVICE	87c580d3-6009-4be9-aea7-13539fbe6e31	2026-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable Orange	ASPIRIN	MAJOR PHARMACEUTICALS	fb3a8e38-e991-49c9-93dc-1d29c0a97ba3	2026-03-05	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Kroger	41e149df-4140-95cc-e063-6294a90a866b	2026-03-03	Warnings	Exact identifier application number: M013
Medique Pain Off	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Sportpharm LLC	2b35acdc-ff88-46e6-a108-5240aac1d53f	2026-03-03	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Best Choice (Valu Merchandisers Company)	a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07	2026-03-03	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	HyVee Inc	6820a515-4004-407b-969b-c4069dc0c3b5	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen, Diphenhydramine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	7be4d67e-1af9-f059-e053-2991aa0a382e	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	1f4ac0e6-e986-4c22-8248-0691d64e1a30	2026-02-26	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	Discount Drug Mart	f413a617-1166-4940-b6ec-fae32238a780	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	19735691-33f3-4e19-85ad-e5f270251ec5	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger	44520aa1-b63f-4239-e063-6394a90a5e14	2026-02-25	Warnings	Exact identifier application number: M013
Leader Extra Strength Effervescent Antacid and Pain Reliever	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Cardinal Health	c5d7bf5f-3e59-52f2-e053-2a95a90a4a00	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	12fd643d-7c60-453f-a81f-407ed20e8725	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d96a1531-772b-4a5c-89e4-66fff1fa3d78	2026-02-25	Warnings	Exact identifier application number: M013
Gentle Care Kit	ZINC OXIDE	Kenvue Brands LLC	4b8f7a5a-2fc4-ea00-e063-6294a90ab95b	2026-02-24	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	444fa225-c204-45d1-b3b3-aa5650ee5d07	2026-02-23	Warnings	Exact identifier application number: M013
Excedrin Extra Strength and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	2c8df1c7-7864-48df-939c-d9ae22e0f52c	2026-02-23	Warnings	Exact identifier application number: M013
Equate Childrens Pain and Fever	ACETAMINOPHEN	Wal-Mart Stores Inc	40eedfe9-54e1-40a2-b4a2-55ff708b89cd	2026-02-23	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