Low Dose Aspirin

Product NDC: 16103-366
11-digit product format: 161030366
Labeler code: 16103
Product ID: 16103-366_9031ec5c-852d-4434-8099-e0fc6fa7b92d
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-08-22
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 · 6 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
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-366-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-366-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16103-366-11	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16103-366-05	`9bebd1f3094a…`	`5416666fcb17…`

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: Low Dose Aspirin
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
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
2763a733-d617-4d95-8429-fbf81d9d77fb	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16103-366-05	2023-06-08	Drug Facts
16103-366-11	2023-06-08	Drug Facts
16103-366-05	2023-01-30	Drug Facts
16103-366-11	2023-01-30	Drug Facts
16103-366-05	2021-03-30	Drug Facts
16103-366-11	2021-03-30	Drug Facts
16103-366-05	2020-01-31	Drug Facts
16103-366-11	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16103-366-05	Low Dose Aspirin	36 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	36	5
16103-366-05	Low Dose Aspirin	1 in 1 CARTON	TABLET, CHEWABLE	1	5
16103-366-11	Low Dose Aspirin	1000 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-366-05	EA - Each	16103-366	43e318c1-7d8b-4f10-84ab-569525198cf9	1	2013-05-02
16103-366-11	EA - Each	16103-366	2d57c73f-13ee-45d4-ba9d-0539d67d4a86	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [CONTRACT PHARMACY SERVICES-PA]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [CONTRACT PHARMACY SERVICES-PA]	1
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-366	LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250101_2763a733-d617-4d95-8429-fbf81d9d77fb.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 16 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain Relief Dye free	ACTEMINOPHEN	BETTER LIVING BRANDS LLC.	41f504d1-29c4-f075-e063-6394a90ad64c	2026-04-11	Warnings	Exact identifier application number: M013
Dr. Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Farmacias De Similares TX LLC	4f1e1f1a-44f4-2356-e063-6294a90a8cdd	2026-04-10	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Akron Pharma Inc.	e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed	2026-04-10	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Akron Pharma Inc.	28413cb3-22c4-40e2-ad6b-42beb438dea3	2026-04-10	Warnings	Exact identifier application number: M013
Pain Reliever Childrens	ACETAMINOPHEN	H E B	7e43de11-d20b-4920-a04d-3c1b5d35e005	2026-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Navajo Manufacturing Company Inc.	f7e572e9-82a7-2127-e053-6394a90ab01a	2026-04-08	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Navajo Manufacturing Company Inc.	f6f2ce71-5728-aefb-e053-6394a90a20e4	2026-04-08	Warnings	Exact identifier application number: M013
Midol	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Navajo Manufacturing Company Inc.	cabd10f2-a91e-4406-9249-915e306c867b	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	HyVee Inc	3730ee46-b241-44eb-94fa-52b9d12a9c35	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Walgreen Company	82cc404b-fcf5-4e48-ab1a-09d8c47f9e04	2026-04-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	9efcce86-dd57-4ea2-ad31-d2038eb61bf1	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	1b164780-ec84-4187-8afa-6f8a0da550fc	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	201b860d-dc3c-4380-affa-e757bf2103cf	2026-04-07	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walgreens	6e7475e2-81a9-43b5-9b81-b58ab761a6f4	2026-04-07	Warnings	Exact identifier application number: M013
Pain Relief Aspirin Low Dose	ASPIRIN	Rite Aid Corporation	503408ed-e799-48a0-8d38-3034f4a0ead5	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Lidl US LLC	468f4a2f-60f7-4808-95d7-a00be1bb112f	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	44de6f5a-0b5c-6c28-e063-6394a90a7e0b	2026-04-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	ARMY AND AIR FORCE EXCHANGE SERVICE	26ae0d0a-34c0-4d16-951a-8d5a463c808b	2026-04-02	Warnings	Exact identifier application number: M013
Pain Reliever plus Sleep Aid NightTime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger Company	286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	COSTCO WHOLESALE CORPORATION	c8a8986b-1ab4-9da0-71da-42595db08b44	2026-04-02	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	859e0fbc-052e-42dd-aa4e-746637ff11f5	11
318272	aspirin 81 MG Chewable Tablet	SCD	859e0fbc-052e-42dd-aa4e-746637ff11f5	11
318272	ASA 81 MG Chewable Tablet	SY	859e0fbc-052e-42dd-aa4e-746637ff11f5	11
318272	aspirin 81 MG Chewable Tablet	PSN	1a3ff0da-85eb-542c-e063-6294a90a9cca	5
318272	aspirin 81 MG Chewable Tablet	PSN	2763a733-d617-4d95-8429-fbf81d9d77fb	5
318272	aspirin 81 MG Chewable Tablet	SCD	1a3ff0da-85eb-542c-e063-6294a90a9cca	5
318272	aspirin 81 MG Chewable Tablet	SCD	2763a733-d617-4d95-8429-fbf81d9d77fb	5
318272	ASA 81 MG Chewable Tablet	SY	1a3ff0da-85eb-542c-e063-6294a90a9cca	5
318272	ASA 81 MG Chewable Tablet	SY	2763a733-d617-4d95-8429-fbf81d9d77fb	5
318272	aspirin 81 MG Chewable Tablet	PSN	390334bc-5c58-4c43-8d1c-6a9dc017891b	1
318272	aspirin 81 MG Chewable Tablet	SCD	390334bc-5c58-4c43-8d1c-6a9dc017891b	1
318272	ASA 81 MG Chewable Tablet	SY	390334bc-5c58-4c43-8d1c-6a9dc017891b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-366-05	16103036605	1 BOTTLE, PLASTIC in 1 CARTON (16103-366-05) / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC	2007-08-22	0000-00-00	No	No	Current
16103-366-11	16103036611	1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-366-11)	2007-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ASPIRIN 81mg Chewable Tablets	PHARMAMED USA INC	2026-02-12	HUMAN OTC DRUG LABEL	5
Drug Facts	Pharbest Pharmaceuticals, Inc.	2025-12-24	HUMAN OTC DRUG LABEL	5
Drug Facts	REMEDYREPACK INC.	2022-07-22	HUMAN OTC DRUG LABEL	6
Drug Facts	A-S Medication Solutions	2021-04-14	HUMAN OTC DRUG LABEL	11
Aspirin Low Dose Chewable Tablets	Contract Pharmacy Services-PA	2010-07-30	HUMAN OTC DRUG LABEL	1