Promethazine Hydrochloride

Product NDC: 21695-703
11-digit product format: 216950703
Labeler code: 21695
Product ID: 21695-703_85f183af-6781-4ceb-9c21-c4ee9a06c355
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA087953
Marketing category: ANDA
Marketing start: 1982-11-15
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 6 mg/5mL
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [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	21695-703		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-703	21695-703-04	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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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	21695-703-04	`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
A087953-001	PROMETHAZINE PLAIN	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087953-001	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	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`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	A087953-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087953-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087953-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087953-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087953-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087953-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087953-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087953-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087953-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087953-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087953-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087953-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087953-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087953-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087953-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087953-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087953-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087953-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087953-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087953-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087953-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087953-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087953-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087953-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087953-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087953-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087953-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087953-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087953-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087953-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087953-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087953-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087953-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087953-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087953-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087953-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087953-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087953-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087953-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087953-001	AA	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
d51697af-7f97-0559-95d1-fe94f3f031d5	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-703-04	2019-09-24	C162847	48780-1	934fe258-4b9c-48b1-e053-8cdaa90a720a	PROMETHAZINE HYDROCHLORIDE SYRUP, USP 6.25 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-703-04	Promethazine Hydrochloride	118 mL in 1 BOTTLE	SYRUP	118		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-703-04	ML - Milliliter	21695-703	64868843-d1b0-46d7-892f-6195ed59345a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
Promethazine	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
sodium propionate	INACTIVE INGREDIENT	DK6Y9P42IN	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-703	PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110113_85f183af-6781-4ceb-9c21-c4ee9a06c355.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
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Atlantic Biologicals Corp.	4f99bbd5-02f7-2fed-e063-6394a90a6355	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087953 application number: ANDA087953
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Xttrium Laboratories, Inc.	302bfea2-d403-d315-e063-6294a90a37dd	2025-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087953 application number: ANDA087953

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992432	promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	85f183af-6781-4ceb-9c21-c4ee9a06c355	1
992432	promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	85f183af-6781-4ceb-9c21-c4ee9a06c355	1
992432	promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	85f183af-6781-4ceb-9c21-c4ee9a06c355	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-703-04	21695070304	118 mL in 1 BOTTLE	118 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE SYRUP, USP 6.25 mg/5 mL	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	1