PROMETHAZINE HYDROCHLORIDE

Manufacturer: DIRECT RX
Effective date: 2016-02-22
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:22:00

Label at a glance#

ProductPROMETHAZINE HYDROCHLORIDE

Active ingredientPROMETHAZINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROMETHAZINE HYDROCHLORIDE 25mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
992447	promethazine HCl 25 MG Oral Tablet	PSN	1
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PROMETHAZINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
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
61919-630-60	2020-01-31	C162847	48780-1	9d75b9d0-e257-f424-e053-dadaa90a57ce	PROMETHAZINE HYDROCHLORIDE 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-630-60	PROMETHAZINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-630	PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX]	1	Legacy NDC, 1 package rows	20160222_2c5d4ccc-5d67-0329-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-630-10	EA - Each	61919-630	fad25e38-6a94-485e-96cf-fced51e3d11d	1	2016-09-02
61919-630-60	EA - Each	61919-630	6315556c-a791-4b2d-bb62-6decb5722607	1	2016-09-02
57664-108-18	EA - Each	57664-108	9b4908a7-15e7-4044-944b-75f993be7651	1	2012-07-24
57664-108-88	EA - Each	57664-108	e8838570-9254-4e8c-9df9-e8ee82895fc3	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

PROMETHAZINE HYDROCHLORIDE
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
PROMETHAZINE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61919-630	61919-630-60
57664-108

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
PROMETHAZINE HYDROCHLORIDE	R61ZEH7I1I	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040863-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30
A040863-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30
A040863-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040863-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040863-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040863-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040863-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040863-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040863-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040863-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040863-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040863-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040863-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040863-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040863-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040863-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040863-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040863-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040863-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040863-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040863-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040863-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040863-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040863-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040863-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040863-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040863-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040863-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040863-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040863-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040863-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040863-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040863-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040863-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040863-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040863-003	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A040863-001	AB	1	`ea1830bbd6c7…`

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
2c5d4ccc-5d68-0329-e054-00144ff88e88			2c5d4ccc-5d67-0329-e054-00144ff88e88	2016-02-22	Warnings, Adverse reactions	Exact identifier spl id: 2c5d4ccc-5d68-0329-e054-00144ff88e88 spl set id: 2c5d4ccc-5d67-0329-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.