Pink Bismuth

Product NDC: 67510-0505
11-digit product format: 675100505
Labeler code: 67510
Product ID: 67510-0505_1a79d259-9965-4ace-ad33-2bc01ba8f2ec
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth Subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: Kareway Product, Inc.
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-08-29
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/15mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67510-0505		I	Inactivated by FDA	2026-10-05
excluded package	package	67510-0505	67510-0505-4	I	Inactivated by FDA	2026-10-05
excluded package	package	67510-0505	67510-0505-6	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 2 · 66 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	67510-0505-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67510-0505-6	`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	67510-0505-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67510-0505-6	`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	67510-0505-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67510-0505-6	`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	67510-0505-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67510-0505-6	`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	67510-0505-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67510-0505-6	`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	67510-0505-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67510-0505-6	`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	67510-0505-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67510-0505-6	`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	67510-0505-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67510-0505-6	`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	67510-0505-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67510-0505-6	`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	67510-0505-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67510-0505-6	`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	67510-0505-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67510-0505-6	`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	67510-0505-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67510-0505-6	`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	67510-0505-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67510-0505-6	`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	67510-0505-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67510-0505-6	`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	67510-0505-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67510-0505-6	`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	67510-0505-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67510-0505-6	`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	67510-0505-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67510-0505-6	`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	67510-0505-4	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67510-0505-6	`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	67510-0505-4	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67510-0505-6	`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	67510-0505-4	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67510-0505-6	`e2bbac7714bc…`	`27bdfed8d636…`

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
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
67510-0505-4	2019-10-29	C162847	48780-1	960f7f55-c9a1-8e05-e053-dbdaa90a074a	Drug Facts
67510-0505-6	2019-10-29	C162847	48780-1	960f7f55-c9a1-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67510-0505-4	Pink Bismuth	120 mL in 1 BOTTLE	LIQUID	120		1
67510-0505-6	Pink Bismuth	177 mL in 1 BOTTLE	LIQUID	177		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
BISMUTH SUBSALICYLATE	ACTIVE MOIETY	62TEY51RR1	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
SODIUM SALICYLATE	INACTIVE INGREDIENT	WIQ1H85SYP	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0505	PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [KAREWAY PRODUCT, INC.]	1	Legacy NDC, 2 package rows	20110831_cdc53b63-b013-4f89-844e-db95b06ba41b.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
308762	bismuth subsalicylate 525 MG in 30 mL Oral Suspension	PSN	cdc53b63-b013-4f89-844e-db95b06ba41b	1
308762	bismuth subsalicylate 17.5 MG/ML Oral Suspension	SCD	cdc53b63-b013-4f89-844e-db95b06ba41b	1
308762	bismuth subsalicylate 1.75 % Oral Suspension	SY	cdc53b63-b013-4f89-844e-db95b06ba41b	1
308762	bismuth subsalicylate 262 MG per 15 ML Oral Suspension	SY	cdc53b63-b013-4f89-844e-db95b06ba41b	1
308762	bismuth subsalicylate 524 MG per 30 ML Oral Suspension	SY	cdc53b63-b013-4f89-844e-db95b06ba41b	1
308762	bismuth subsalicylate 525 MG per 30 ML Oral Suspension	SY	cdc53b63-b013-4f89-844e-db95b06ba41b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67510-0505-4	67510050504	120 mL in 1 BOTTLE	120 ml	Historical
67510-0505-6	67510050506	177 mL in 1 BOTTLE	177 ml	Historical