Aspirin 81 mg Enteric Coated

Product NDC: 69618-046
11-digit product format: 696180046
Labeler code: 69618
Product ID: 69618-046_9b804b47-d4ce-fb99-e053-2995a90a3e52
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin
Dosage form: TABLET
Route: ORAL
Labeler: Reliable 1 Laboratories LLC
Application: part343
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-05-10
Marketing end: 0000-00-00
Substance: ASPIRIN
Active strength: 81 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69618-046		I	Inactivated by FDA	2026-10-12
excluded package	package	69618-046	69618-046-02	I	Inactivated by FDA	2026-10-12
excluded package	package	69618-046	69618-046-10	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 1 · 27 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	69618-046-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69618-046-02	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	69618-046-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69618-046-02	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	69618-046-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69618-046-02	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	69618-046-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69618-046-02	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	69618-046-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69618-046-02	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	69618-046-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69618-046-02	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	69618-046-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69618-046-10	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	69618-046-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69618-046-10	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	69618-046-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69618-046-10	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
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808
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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69618-046-02	2025-01-30	C162847	48780-1	2cef2736-a3ac-d83d-e063-dadaa90ab31f	Aspirin USP 81mg Enteric Coated Tablet
69618-046-10	2025-01-30	C162847	48780-1	2cef2736-a3ac-d83d-e063-dadaa90ab31f	Aspirin USP 81mg Enteric Coated Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-046-02	Aspirin 81 mg Enteric Coated	120 in 1 BOTTLE	TABLET	120		4
69618-046-10	Aspirin 81 mg Enteric Coated	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-046-02	EA - Each	69618-046	eac74962-bc01-429c-aecd-ba6590238b1b	1	2018-10-11
69618-046-10	EA - Each	69618-046	41f396b9-ebf9-486a-a42e-e9c3e03ebf48	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-046	ASPIRIN 81 MG ENTERIC COATED (ASPIRIN) TABLET [RELIABLE 1 LABORATORIES LLC]	4	Legacy NDC, 2 package rows	20230331_6c6cf852-6821-59e1-e053-2a91aa0a4021.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	6c6cf852-6821-59e1-e053-2a91aa0a4021	4
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	6c6cf852-6821-59e1-e053-2a91aa0a4021	4
308416	ASA 81 MG Delayed Release Oral Tablet	SY	6c6cf852-6821-59e1-e053-2a91aa0a4021	4
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	6c6cf852-6821-59e1-e053-2a91aa0a4021	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69618-046-02	69618004602	120 TABLET in 1 BOTTLE (69618-046-02)	120 tablet	2018-05-10	0000-00-00	No	No	Current
69618-046-10	69618004610	1000 TABLET in 1 BOTTLE, PLASTIC (69618-046-10)	1000 tablet	2018-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aspirin USP 81mg Enteric Coated Tablet	Reliable 1 Laboratories LLC	2023-03-29	HUMAN OTC DRUG LABEL	4
Aspirin USP 81mg Enteric Coated Tablet	Quality Care Products, LLC	2021-04-16	HUMAN OTC DRUG LABEL	3
Aspirin USP 81mg Enteric Coated Tablet	REMEDYREPACK INC.	2019-10-03	HUMAN OTC DRUG LABEL	3