Adult Low Dose

Product NDC: 71309-003
11-digit product format: 713090003
Labeler code: 71309
Product ID: 71309-003_d906461e-18f9-4572-e053-2a95a90a5d43
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin 81 mg
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Safrel Pharmaceuticals, LLC.
Application: part343
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-02-09
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71309-003		I	Inactivated by FDA	2026-10-12
excluded package	package	71309-003	71309-003-02	I	Inactivated by FDA	2026-10-12
excluded package	package	71309-003	71309-003-05	I	Inactivated by FDA	2026-10-12
excluded package	package	71309-003	71309-003-10	I	Inactivated by FDA	2026-10-12
excluded package	package	71309-003	71309-003-25	I	Inactivated by FDA	2026-10-12
excluded package	package	71309-003	71309-003-50	I	Inactivated by FDA	2026-10-12
excluded package	package	71309-003	71309-003-60	I	Inactivated by FDA	2026-10-12

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71309-003-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71309-003-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71309-003-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71309-003-50	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71309-003-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71309-003-25	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71309-003-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71309-003-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71309-003-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71309-003-50	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71309-003-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71309-003-25	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71309-003-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71309-003-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71309-003-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71309-003-50	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71309-003-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71309-003-25	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71309-003-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71309-003-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71309-003-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71309-003-50	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71309-003-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71309-003-25	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71309-003-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71309-003-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71309-003-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71309-003-50	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71309-003-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71309-003-25	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71309-003-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71309-003-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71309-003-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71309-003-50	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71309-003-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71309-003-25	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71309-003-50	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71309-003-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71309-003-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71309-003-25	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71309-003-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71309-003-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71309-003-50	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71309-003-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71309-003-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71309-003-25	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71309-003-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71309-003-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71309-003-50	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71309-003-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71309-003-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
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
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, Related label table
NDC	Related label
71309-003-02	Aspirin 81 mg Enteric Coated Tablets
71309-003-05	Aspirin 81 mg Enteric Coated Tablets
71309-003-10	Aspirin 81 mg Enteric Coated Tablets
71309-003-25	Aspirin 81 mg Enteric Coated Tablets
71309-003-50	Aspirin 81 mg Enteric Coated Tablets
71309-003-60	Aspirin 81 mg Enteric Coated Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71309-003-01	Adult Low Dose	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	6
71309-003-02	Adult Low Dose	2 in 1 POUCH	TABLET, DELAYED RELEASE	2	6
71309-003-05	Adult Low Dose	500 in 1 BOTTLE	TABLET, DELAYED RELEASE	500	6
71309-003-10	Adult Low Dose	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	6
71309-003-25	Adult Low Dose	25 in 1 BOX	TABLET, DELAYED RELEASE	25	6
71309-003-25	Adult Low Dose	2 in 1 POUCH	TABLET, DELAYED RELEASE	2	6
71309-003-30	Adult Low Dose	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	6
71309-003-30	Adult Low Dose	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	6
71309-003-50	Adult Low Dose	50 in 1 BOX	TABLET, DELAYED RELEASE	50	6
71309-003-50	Adult Low Dose	2 in 1 POUCH	TABLET, DELAYED RELEASE	2	6
71309-003-60	Adult Low Dose	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	6
71309-003-60	Adult Low Dose	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	6
71309-003-65	Adult Low Dose	365 in 1 BOTTLE	TABLET, DELAYED RELEASE	365	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71309-003	ADULT LOW DOSE (ASPIRIN 81 MG) TABLET, DELAYED RELEASE [SAFREL PHARMACEUTICALS, LLC.]	6	Legacy NDC, 13 package rows	20230329_87401db3-7162-b48b-e053-2a95a90ac98f.zip

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	87401db3-7162-b48b-e053-2a95a90ac98f	6
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	87401db3-7162-b48b-e053-2a95a90ac98f	6
308416	ASA 81 MG Delayed Release Oral Tablet	SY	87401db3-7162-b48b-e053-2a95a90ac98f	6
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	87401db3-7162-b48b-e053-2a95a90ac98f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71309-003-01	71309000301	1000 BOTTLE in 1 BOTTLE (71309-003-01) > 365 BOTTLE in 1 BOTTLE (71309-003-65) > 30 CARTON in 1 BOTTLE (71309-003-30) > 1 TABLET, DELAYED RELEASE in 1 CARTON	1000 bottle	2017-06-05	0000-00-00	No	No	Current
71309-003-02	71309000302	2 POUCH in 1 POUCH (71309-003-02) > 2 TABLET, DELAYED RELEASE in 1 POUCH	2 pouch	2017-06-05	0000-00-00	No	No	Current
71309-003-05	71309000305	500 BOTTLE in 1 BOTTLE (71309-003-05) > 1000 BOTTLE in 1 BOTTLE (71309-003-01) > 365 BOTTLE in 1 BOTTLE (71309-003-65) > 30 CARTON in 1 BOTTLE (71309-003-30) > 1 TABLET, DELAYED RELEASE in 1 CARTON	500 bottle	2021-01-09	0000-00-00	No	No	Current
71309-003-10	71309000310	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (71309-003-10)		2016-02-09	0000-00-00	No	No	Current
71309-003-25	71309000325	25 POUCH in 1 BOX (71309-003-25) > 2 TABLET, DELAYED RELEASE in 1 POUCH	25 pouch	2017-06-05	0000-00-00	No	No	Current
71309-003-30	71309000330	30 in 1 BOTTLE						Historical
71309-003-50	71309000350	50 POUCH in 1 BOX (71309-003-50) > 2 TABLET, DELAYED RELEASE in 1 POUCH	50 pouch	2017-06-05	0000-00-00	No	No	Current
71309-003-60	71309000360	1 BOTTLE in 1 CARTON (71309-003-60) > 60 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2017-06-05	0000-00-00	No	No	Current
71309-003-65	71309000365	365 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aspirin 81 mg Enteric Coated Tablets	Safrel Pharmaceuticals, LLC.	2023-03-28	HUMAN OTC DRUG LABEL	6