Promethazine Hydrochloride

Product NDC: 0121-1854
11-digit product format: 001211854
Labeler code: 0121
Product ID: 0121-1854_628c0c05-9610-4a8e-ae9b-f6aad47993d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA040643
Marketing category: ANDA
Marketing start: 2025-08-07
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 6.25 mg/5mL
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A040643-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA		2006-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040643-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2006-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040643-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2006-04-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040643-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040643-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040643-001	AA	1	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040643-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040643-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040643-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040643-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040643-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040643-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040643-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040643-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040643-001	AA	1	`8869cabd3fbd…`
2019-12-14 00:12 UTC	2019-12	A040643-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040643-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040643-001	AA	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040643-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040643-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040643-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040643-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040643-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040643-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040643-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040643-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040643-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Promethazine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	6.25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R61ZEH7I1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992432	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7a186bcd-ab8c-4695-8289-4cd33bb551cf	Available on FDA.report

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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-1854-16	Promethazine Hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1854-16	ML - Milliliter	0121-1854	0a369afc-f79c-4ce0-bd93-30f5abf78a43	1	2025-08-11

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	7a186bcd-ab8c-4695-8289-4cd33bb551cf	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040643 application number: ANDA040643 ndc (product): 0121-1854

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	7a186bcd-ab8c-4695-8289-4cd33bb551cf	11
992432	promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	7a186bcd-ab8c-4695-8289-4cd33bb551cf	11
992432	promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	7a186bcd-ab8c-4695-8289-4cd33bb551cf	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-1854-16	00121185416	473 mL in 1 BOTTLE (0121-1854-16)	473 ml	2025-08-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Plain Oral Solution (Promethazine Hydrochloride Oral Solution, USP) Rx Only	PAI Holdings, LLC dba PAI Pharma	2025-08-05	HUMAN PRESCRIPTION DRUG LABEL	11