Home NDC 71872-7242 DIPHENHYDRAMINE HYDROCHLORIDE
Product NDC 71872-7242
11-digit product format 718727242
Labeler code 71872
Product ID 71872-7242_fa59581e-a76f-d735-e053-6294a90acd1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Medical Purchasing Solutions, LLC
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 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 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 · 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 A087513-001 DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML ELIXIR / ORAL AA RLD, RS 1982-02-10 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A087513-001 AA 1 caaa826d4ba7…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 71872-7242-1 DIPHENHYDRAMINE HYDROCHLORIDE 1 in 1 BAG SOLUTION 1 2 71872-7242-1 DIPHENHYDRAMINE HYDROCHLORIDE 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71872-7242 DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20230429_bf7ab250-38b0-ba29-e053-2a95a90a8f32.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 Marketing start Marketing end Sample Exclude flag Status 71872-7242-1 71872724201 1 CUP, UNIT-DOSE in 1 BAG (71872-7242-1) / 10 mL in 1 CUP, UNIT-DOSE 2021-03-01 0000-00-00 No No Current