Alka Seltzer

Product NDC: 53666-100
11-digit product format: 536660100
Labeler code: 53666
Product ID: 53666-100_c5cec0f6-56ff-4544-a932-a133ad26c2d4
Type: HUMAN OTC DRUG
Nonproprietary name: ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE
Dosage form: TABLET, EFFERVESCENT
Route: ORAL
Labeler: Salimex, S.A.
Application: part343
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-10-10
Marketing end: 0000-00-00
Substance: ASPIRIN; ANHYDROUS CITRIC ACID; SODIUM BICARBONATE
Active strength: 325 mg/1; mg/1; mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53666-100		I	Inactivated by FDA		2026-10-16
excluded package	package	53666-100	53666-100-10	I	Inactivated by FDA		2026-10-16

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53666-100-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53666-100-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53666-100-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53666-100-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53666-100-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53666-100-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53666-100-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53666-100-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53666-100-10	`0efc9e666f02…`	`f202fb6c5f17…`
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	53666-100-10	`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	53666-100-10	`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	53666-100-10	`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	53666-100-10	`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	53666-100-10	`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	53666-100-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53666-100-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53666-100-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53666-100-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53666-100-10	`8dfbde2a14a4…`	`c9ff85d89658…`
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	53666-100-10	`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	53666-100-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53666-100-10	`110d247fa046…`	`a55b01930146…`

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
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53666-100-10	2021-01-29	C162847	48780-1	9855d018-d559-cd31-e053-dbdaa90ab51a	Alka Seltzer
53666-100-10	2019-11-27	C162847	48780-1	9855d018-d559-cd31-e053-dbdaa90ab51a	Alka Seltzer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53666-100-10	Alka Seltzer	100 in 1 BOX	TABLET, EFFERVESCENT	100		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ANHYDROUS CITRIC ACID	ACTIVE INGREDIENT	XF417D3PSL	ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]	3
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]	3
SODIUM BICARBONATE	ACTIVE INGREDIENT	8MDF5V39QO	ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]	3
ANHYDROUS CITRIC ACID	ACTIVE MOIETY	XF417D3PSL	ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]	3
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]	3
BICARBONATE ION	ACTIVE MOIETY	HN1ZRA3Q20	ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53666-100	ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]	3	Legacy NDC, 1 package rows	20121114_73e85be6-1236-453b-b41c-37381a054773.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
XF417D3PSL	ANHYDROUS CITRIC ACID	77-92-9	ANHYDROUS CITRIC ACID
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1536680	Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral Tablet	PSN	73e85be6-1236-453b-b41c-37381a054773	3
1536675	aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet	PSN	73e85be6-1236-453b-b41c-37381a054773	3
1536680	aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]	SBD	73e85be6-1236-453b-b41c-37381a054773	3
1536675	aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet	SCD	73e85be6-1236-453b-b41c-37381a054773	3
1536680	Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral Tablet	SY	73e85be6-1236-453b-b41c-37381a054773	3
1536675	ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet	SY	73e85be6-1236-453b-b41c-37381a054773	3
1536680	ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]	SY	73e85be6-1236-453b-b41c-37381a054773	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53666-100-10	53666010010	100 in 1 BOX	Historical