Home NDC 55154-9363 Diphenhydramine Hydrochloride
Product NDC 55154-9363
11-digit product format 551549363
Labeler code 55154
Product ID 55154-9363_7bf6446b-a127-4c1a-b601-857d786025dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Cardinal Health 107, LLC
Application ANDA040466
Marketing category ANDA
Marketing start 2002-08-01
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 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 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040466-001 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 · 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 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040466-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2002-05-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 1723740 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-9363-5 Diphenhydramine Hydrochloride 1 mL in 1 VIAL INJECTION, SOLUTION 1 12 55154-9363-5 Diphenhydramine Hydrochloride 5 in 1 BAG INJECTION, SOLUTION 5 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-9363 DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] 12 Current NDC, Legacy NDC, 2 package rows 20250503_50df93bf-fe72-48f6-a02e-ea9a313d47c2.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 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 9713d8ee-6ab2-2fdf-e053-2a95a90a9e19 2026-05-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040466 application number: ANDA040466 Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE Cardinal Health 107, LLC 50df93bf-fe72-48f6-a02e-ea9a313d47c2 2026-05-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040466 application number: ANDA040466 ndc (product): 55154-9363 Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE Fresenius Kabi USA, LLC f4f0c26b-dad0-47a1-a9e7-6558c11254c0 2025-04-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040466 application number: ANDA040466 Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE Fresenius Kabi USA, LLC fc574e74-1fdc-4a61-a1ed-492ae43faed2 2025-02-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040466 application number: ANDA040466 Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE Fresenius Kabi USA, LLC 921b9f64-1096-46db-866a-67f0f9ff6790 2024-10-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040466 application number: ANDA040466 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 7b9ed8ef-ce21-19e7-e053-2a91aa0a81be 2022-12-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040466 application number: ANDA040466
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-9363-5 55154936305 5 VIAL in 1 BAG (55154-9363-5) / 1 mL in 1 VIAL 5 vial 2002-08-01 0000-00-00 No No Current