Upset Stomach Relief

Product NDC: 21130-469
11-digit product format: 211300469
Labeler code: 21130
Product ID: 21130-469_fb60983c-3d28-49d4-b907-ef97acf2990c
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Safeway
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-08-08
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21130-469		I	Inactivated by FDA		2026-10-05
excluded package	package	21130-469	21130-469-65	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 · 30 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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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	21130-469-65	`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
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
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
21130-469-65	2024-01-30	C162847	48780-1	1030e364-fbbc-111a-e063-dadaa90a10e2	Upset Stomach Relief Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-469-65	Upset Stomach Relief	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6		4
21130-469-65	Upset Stomach Relief	5 in 1 CARTON	TABLET, CHEWABLE	5		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-469	UPSET STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SAFEWAY]	4	Legacy NDC, 2 package rows	20220113_b99e0244-e5f7-4b81-9eaa-117cffd0b79e.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
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	b99e0244-e5f7-4b81-9eaa-117cffd0b79e	4
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	b99e0244-e5f7-4b81-9eaa-117cffd0b79e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-469-65	21130046965	5 BLISTER PACK in 1 CARTON (21130-469-65) > 6 TABLET, CHEWABLE in 1 BLISTER PACK	5 blister pack	2015-08-08	0000-00-00	No	No	Current