Diphenhydramine Hydrochloride

Product NDC: 76045-235
Requested package NDC: 76045-235-10
11-digit product format: 760450235
Labeler code: 76045
Product ID: 76045-235_5bfd2f08-2d90-47b1-9677-73c503e66956
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA091526
Marketing category: ANDA
Marketing start: 2025-06-02
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 1.

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
A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2013-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091526-001	AP

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091526-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091526-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091526-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091526-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091526-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091526-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091526-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091526-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091526-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091526-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091526-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091526-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091526-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091526-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091526-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091526-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091526-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091526-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091526-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091526-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091526-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091526-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091526-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091526-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091526-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091526-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091526-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091526-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091526-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091526-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091526-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091526-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091526-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091526-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091526-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091526-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091526-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091526-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091526-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091526-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049289	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
6d1aa0e2-036d-4382-a458-fc0300dba7cb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76045-235-01	Diphenhydramine Hydrochloride	1 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	1	13
76045-235-01	Diphenhydramine Hydrochloride	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	13
76045-235-10	Diphenhydramine Hydrochloride	24 in 1 CARTON	INJECTION, SOLUTION	24	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]	7
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]	7
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]	7
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]	7
Water	INACTIVE INGREDIENT	059QF0KO0R	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]	7

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
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	6d1aa0e2-036d-4382-a458-fc0300dba7cb	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091526 application number: ANDA091526 ndc (package): 76045-235-10 ndc (product): 76045-235 ndc11 (package): 76045023510

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049289	diphenhydrAMINE HCl 50 MG in 1 ML Prefilled Syringe	PSN	6d1aa0e2-036d-4382-a458-fc0300dba7cb	13
1049289	1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled Syringe	SCD	6d1aa0e2-036d-4382-a458-fc0300dba7cb	13
1049289	diphenhydramine HCl 50 MG per 1 ML Prefilled Syringe	SY	6d1aa0e2-036d-4382-a458-fc0300dba7cb	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76045-235-10	76045023510	24 BLISTER PACK in 1 CARTON (76045-235-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-235-01) / 1 mL in 1 SYRINGE, GLASS	24 blister pack	2025-06-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DiphenhydrAMINE Hydrochloride Injection, USP	Fresenius Kabi USA, LLC \| Fresenius Kabi, USA LLC	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	13