QC Quality Choice Pink Bismuth Stomach Relief

Product NDC: 63868-303
Requested package NDC: 63868-303-12
11-digit product format: 638680303
Labeler code: 63868
Product ID: 63868-303_032234ec-de62-42ca-ba2e-b6ec9154c789
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Chain Drug Manufacturing Assn
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-03-20
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/15mL
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	63868-303	63868-303-12	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 · 16 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…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
63868-303-08	2024-01-30	ba0f9c33-3252-a910-e053-dadaa90a0b85	QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 8 FL OZ
63868-303-12	2024-01-30	ba0f9c33-466e-a910-e053-dadaa90a0b85	QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 12FL OZ 354 mL
63868-303-08	2022-01-18	ba0f9c33-3252-a910-e053-dadaa90a0b85	QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 8 FL OZ
63868-303-12	2022-01-18	ba0f9c33-466e-a910-e053-dadaa90a0b85	QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 12FL OZ 354 mL
63868-303-08	2021-01-29	ba0f9c33-3252-a910-e053-dadaa90a0b85	QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 8 FL OZ
63868-303-12	2021-01-29	ba0f9c33-466e-a910-e053-dadaa90a0b85	QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 12FL OZ 354 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-303-08	QC Quality Choice Pink Bismuth Stomach Relief	236 mL in 1 BOTTLE, PLASTIC	SUSPENSION	236		3
63868-303-12	QC Quality Choice Pink Bismuth Stomach Relief	354 mL in 1 BOTTLE, PLASTIC	SUSPENSION	354		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-303-08	ML - Milliliter	63868-303	9e8fd258-6432-4098-9494-71fc7a2b0727	1	2024-05-16
63868-303-12	ML - Milliliter	63868-303	20d2a458-ff0b-4c5f-aaf9-964af3211307	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-303	QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [CHAIN DRUG MANUFACTURING ASSN]	3	Legacy NDC, 1 package rows	20220119_bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572.zip
63868-303	QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [CHAIN DRUG MANUFACTURING ASSN]	3	Legacy NDC, 1 package rows	20220119_a23ac67d-bb35-4778-8ac3-a52078368942.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	a23ac67d-bb35-4778-8ac3-a52078368942	3
308762	bismuth subsalicylate 525 MG in 30 mL Oral Suspension	PSN	bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572	3
308762	bismuth subsalicylate 17.5 MG/ML Oral Suspension	SCD	a23ac67d-bb35-4778-8ac3-a52078368942	3
308762	bismuth subsalicylate 17.5 MG/ML Oral Suspension	SCD	bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572	3
308762	bismuth subsalicylate 1.75 % Oral Suspension	SY	a23ac67d-bb35-4778-8ac3-a52078368942	3
308762	bismuth subsalicylate 1.75 % Oral Suspension	SY	bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572	3
308762	bismuth subsalicylate 262 MG per 15 ML Oral Suspension	SY	a23ac67d-bb35-4778-8ac3-a52078368942	3
308762	bismuth subsalicylate 262 MG per 15 ML Oral Suspension	SY	bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572	3
308762	bismuth subsalicylate 524 MG per 30 ML Oral Suspension	SY	a23ac67d-bb35-4778-8ac3-a52078368942	3
308762	bismuth subsalicylate 524 MG per 30 ML Oral Suspension	SY	bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572	3
308762	bismuth subsalicylate 525 MG per 30 ML Oral Suspension	SY	a23ac67d-bb35-4778-8ac3-a52078368942	3
308762	bismuth subsalicylate 525 MG per 30 ML Oral Suspension	SY	bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-303-12	63868030312	354 mL in 1 BOTTLE, PLASTIC (63868-303-12)	354 ml	2015-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 8 FL OZ	Chain Drug Manufacturing Assn	2022-01-18	HUMAN OTC DRUG LABEL	3
QC Quality Choice Pink Bismuth Stomach Relief Original Flavor 12FL OZ 354 mL	Chain Drug Manufacturing Assn	2022-01-18	HUMAN OTC DRUG LABEL	3