Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride

Product NDC: 70556-103
11-digit product format: 705560103
Labeler code: 70556
Product ID: 70556-103_0a416c16-2a51-4567-a9b5-01dff63230d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules
Dosage form: KIT
Labeler: Ailex Pharmaceuticals, LLC
Application: ANDA202584
Marketing category: ANDA
Marketing start: 2018-11-30
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
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	70556-103		I	Inactivated by FDA		2026-08-17
excluded package	package	70556-103	70556-103-14	I	Inactivated by FDA		2026-08-17

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 · 38 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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`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	70556-103-14	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL		RS	2018-11-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202584-001	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RS	2018-11-30	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55	Product name	5	20251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17	Product name	1	20250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1	Product name	5	20250515
e1aac33b-94ae-4ee9-905b-299f7263853b	Product name	3	20250124
16642716-d28a-4f90-8dcb-3921cd8c8109	Product name	4	20240516
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
151122cd-8b80-4972-8b02-3a4dda642fbc	Product name	2	20200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
0add4de9-d152-3375-3390-1123dddc5e3d	Product name	1	20140508
33ca0fcc-1011-92dc-50a9-a383683eed1e	Product name	1	20140508
53f39d9f-cd3f-04e1-c668-d4580719d57d	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70556-103-14	2021-01-29	C162847	48780-1	ba0f9c33-5306-a910-e053-dadaa90a0b85	Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70556-103-14	Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride	4 in 1 BLISTER PACK	KIT	4		2
70556-103-14	Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride	14 in 1 CARTON	KIT	14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70556-103	BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE (BISMUTH SUBSALICYLATE CHEWABLE TABLETS/METRONIDAZOLE TABLETS/TETRACYCLINE HYDROCHLORIDE CAPSULES) KIT [AILEX PHARMACEUTICALS, LLC]	2	Legacy NDC, 2 package rows	20191125_0c809fa5-c630-4bf1-a0fc-5ee875008807.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
758019	{112 (bismuth subsalicylate 262 MG Chewable Tablet) / 56 (metronidazole 250 MG Oral Tablet) / 56 (tetracycline hydrochloride 500 MG Oral Capsule) } Pack	GPCK	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
758019	bismuth subsalicylate 262 MG Chewable Tablet (112) / metroNIDAZOLE 250 MG Oral Tablet (56) / tetracycline HCl 500 MG Oral Capsule (56) Pack	PSN	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
198252	tetracycline HCl 500 MG Oral Capsule	PSN	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
314106	metronidazole 250 MG Oral Tablet	SCD	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
198252	tetracycline hydrochloride 500 MG Oral Capsule	SCD	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
198252	tetracycline (as tetracycline hydrochloride) 500 MG Oral Capsule	SY	0c809fa5-c630-4bf1-a0fc-5ee875008807	2
198252	tetracycline HCl 500 MG Oral Capsule	SY	0c809fa5-c630-4bf1-a0fc-5ee875008807	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
70556-103-14	70556010314	4 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules	Ailex Pharmaceuticals, LLC	2019-11-24	HUMAN PRESCRIPTION DRUG LABEL	2