Nystatin

Product NDC: 42254-067
11-digit product format: 422540067
Labeler code: 42254
Product ID: 42254-067_ceb0fc2d-9039-4961-84b6-ceb2a2649c50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA062512
Marketing category: ANDA
Marketing start: 1995-04-15
Marketing end: 0000-00-00
Substance: NYSTATIN
Active strength: 100000 [USP'U]/mL
Pharmacologic classes: Polyene Antifungal [EPC],Polyenes [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-067		I	Inactivated by FDA		2026-08-17
excluded package	package	42254-067	42254-067-60	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 · 44 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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`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	42254-067-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-067-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-067-60	`110d247fa046…`	`a55b01930146…`

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
A062512-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A062512-001	AA

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A062512-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062512-001	AA	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-067-60	2019-09-24	C162847	48780-1	9350213a-3d97-c013-e053-90daa90a1393	NYSTATIN ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-067-60	Nystatin	60 mL in 1 BOTTLE, GLASS	SUSPENSION	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-067-60	ML - Milliliter	42254-067	255b6506-edf6-4d6a-9e48-5904956f603b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
Nystatin	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
potassium phosphate, dibasic	INACTIVE INGREDIENT	CI71S98N1Z	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-067	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120411_ceb0fc2d-9039-4961-84b6-ceb2a2649c50.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin Oral Suspension	NYSTATIN	Xttrium Laboratories, Inc.	4a670371-d373-1ba6-e063-6394a90a13b6	2026-02-06	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512
Nystatin	NYSTATIN	A-S Medication Solutions	e069d495-7f1a-4970-8f4d-aa93d124b3fc	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BDF1O1C72E	NYSTATIN	1400-61-9	NYSTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	ceb0fc2d-9039-4961-84b6-ceb2a2649c50	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	ceb0fc2d-9039-4961-84b6-ceb2a2649c50	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	ceb0fc2d-9039-4961-84b6-ceb2a2649c50	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	ceb0fc2d-9039-4961-84b6-ceb2a2649c50	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42254-067-60	42254006760	60 mL in 1 BOTTLE, GLASS	60 ml	Historical