Estomaquil Polvo

Product NDC: 51769-108
Requested package NDC: 51769-108-20
11-digit product format: 517690108
Labeler code: 51769
Product ID: 51769-108_e272c1cf-9795-0abd-e053-2995a90a2229
Type: HUMAN OTC DRUG
Nonproprietary name: BISMUTH SUBSALICYLATE
Dosage form: POWDER
Route: ORAL
Labeler: All Natural Dynamics
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-06-27
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51769-108	51769-108-20	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51769-108-20	2023-07-28	C162847	48780-1	0191ceaa-69db-198a-e063-dbdaa90aec3e	Estomaquil ® Polvo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51769-108-20	Estomaquil Polvo	1 in 1 POUCH	POWDER	1		1
51769-108-20	Estomaquil Polvo	20 in 1 CARTON	POWDER	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51769-108	ESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [ALL NATURAL DYNAMICS ]	1	Legacy NDC, 2 package rows	20220629_e272c1cf-9793-0abd-e053-2995a90a2229.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
62TEY51RR1	BISMUTH SUBSALICYLATE	14882-18-9	BISMUTH SUBSALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1721449	bismuth subsalicylate 262 MG Powder for Oral Suspension	PSN	e272c1cf-9793-0abd-e053-2995a90a2229	1
1721455	Estomaquil 262 MG Powder for Oral Suspension	PSN	e272c1cf-9793-0abd-e053-2995a90a2229	1
1721455	bismuth subsalicylate 262 MG Powder for Oral Suspension [Estomaquil]	SBD	e272c1cf-9793-0abd-e053-2995a90a2229	1
1721449	bismuth subsalicylate 262 MG Powder for Oral Suspension	SCD	e272c1cf-9793-0abd-e053-2995a90a2229	1
1721455	Estomaquil 262 MG Powder for Oral Suspension	SY	e272c1cf-9793-0abd-e053-2995a90a2229	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51769-108-20	51769010820	20 POUCH in 1 CARTON (51769-108-20) > 1 POWDER in 1 POUCH	20 pouch	2022-06-27	0000-00-00	No	No	Current