Diphenhydramine Hydrochloride

Product NDC: 70518-1082
Requested package NDC: 70518-1082-1
11-digit product format: 705181082
Labeler code: 70518
Product ID: 70518-1082_485992c3-e3e0-e79a-e063-6294a90a655b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diphenhydramine hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA080817
Marketing category: ANDA
Marketing start: 2018-03-27
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: 2027-12-31
Current FDA listing: Yes

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1082	70518-1082-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1082	70518-1082-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1082	70518-1082-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1082	70518-1082-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`

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
A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080817-002	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080817-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`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	A080817-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080817-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080817-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080817-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080817-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080817-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080817-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080817-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080817-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080817-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080817-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080817-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080817-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080817-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080817-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080817-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080817-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080817-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080817-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080817-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080817-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080817-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080817-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080817-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080817-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080817-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080817-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080817-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080817-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080817-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080817-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080817-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080817-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080817-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080817-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080817-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080817-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080817-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080817-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080817-002	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenhydramine Hydrochloride
Listing expiration: 2027-12-31

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
1049633	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
62edde3d-b41b-40fc-ac18-b749035de831	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-1082-1	2023-03-06	C162847	48780-1	f386c64a-44b3-0266-e053-dadaa90a7c1a	Diphenhydramine Hydrochloride Injection, USP Rx only
70518-1082-1	2023-01-30	C162847	48780-1	f386c64a-44b3-0266-e053-dadaa90a7c1a	Diphenhydramine Hydrochloride Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-1082-0	Diphenhydramine Hydrochloride	1 mL in 1 VIAL	INJECTION	1		16
70518-1082-1	Diphenhydramine Hydrochloride	25 in 1 PACKAGE	INJECTION	25		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1082	DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]	14	Current NDC, Legacy NDC, 2 package rows	20250522_62edde3d-b41b-40fc-ac18-b749035de831.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Sportpharm LLC	e5af2dd2-cc91-46c7-bdb9-97a7cdddcb69	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	d32d074a-f1b6-4a9a-8e10-e19f0e67c61b	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	eedb421c-0020-4e5f-8b09-26a1cbabb681	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	5af966ae-535b-492b-ba2c-eeb4e40be959	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	62edde3d-b41b-40fc-ac18-b749035de831	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817 ndc (package): 70518-1082-1 ndc (product): 70518-1082 ndc11 (package): 70518108201
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Henry Schein, Inc.	af972e71-62ab-40c6-925a-cbcb4d6720a4	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	b39836d7-2d3a-4a0f-88dc-ca230c82d2a1	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	829bbcbf-fb27-4484-aff6-a7e7467670af	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ec691492-a295-4b48-a1a3-5824931efa97	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA Health First	738f2ce3-520c-b3a2-e053-2a91aa0af324	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6671c8d0-1f5d-0d77-e053-2a91aa0a7585	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080817 application number: ANDA080817

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
1049633	diphenhydrAMINE HCl 50 MG/ML Injectable Solution	PSN	62edde3d-b41b-40fc-ac18-b749035de831	16
1049633	diphenhydramine hydrochloride 50 MG/ML Injectable Solution	SCD	62edde3d-b41b-40fc-ac18-b749035de831	16
1049633	diphenhydramine HCl 50 MG/ML Injectable Solution	SY	62edde3d-b41b-40fc-ac18-b749035de831	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1082-1	70518108201	25 VIAL in 1 PACKAGE (70518-1082-1) / 1 mL in 1 VIAL (70518-1082-0)	25 vial	2018-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine Hydrochloride Injection, USP Rx only	REMEDYREPACK INC.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	16