Home NDC 0121-0978 DIPHENHYDRAMINE HYDROCHLORIDE
Product NDC 0121-0978
11-digit product format 001210978
Labeler code 0121
Product ID 0121-0978_b7eb09fa-58fb-4c3f-ad65-a04965bc52b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA087513
Marketing category ANDA
Marketing start 1982-02-10
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/10mL
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 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL AA RLD, RS 1982-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087513-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RLD, RS 1982-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL RS 1982-02-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A087513-001 AA 1 a50c72e98297…
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 25 mg/10mL
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 1049906 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 0121-0978-00 DIPHENHYDRAMINE HYDROCHLORIDE 10 in 1 TRAY SOLUTION 10 12 0121-0978-00 DIPHENHYDRAMINE HYDROCHLORIDE 10 in 1 CASE SOLUTION 10 12 0121-0978-10 DIPHENHYDRAMINE HYDROCHLORIDE 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0978 DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 12 Current NDC, Legacy NDC, 3 package rows 20240410_6fe6fe2d-4405-4e7a-a2ed-5eb367d52842.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 · 3 matching rows.
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 0121-0978-00 00121097800 10 TRAY in 1 CASE (0121-0978-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10) 10 tray 1982-02-10 0000-00-00 No No Current 0121-0978-10 00121097810 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical