Home NDC 64950-345 Promethazine Hydrochloride and Phenylephrine Hydrochloride
Product NDC 64950-345
11-digit product format 649500345
Labeler code 64950
Product ID 64950-345_df5aecd4-2175-4495-b6cc-13d69e718d09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride and phenylephrine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Genus Lifesciences Inc.
Application ANDA040654
Marketing category ANDA
Marketing start 2024-07-15
Substance PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Active strength 5; 6.25 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [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 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040654-001 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 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040654-001 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE 5MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-12-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Promethazine Hydrochloride and Phenylephrine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 5 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R61ZEH7I1I Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1248057 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 64950-345-16 Promethazine Hydrochloride and Phenylephrine Hydrochloride 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-345 PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.] 1 Current NDC, 1 package rows 20240724_7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64950-345-16 64950034516 473 mL in 1 BOTTLE, PLASTIC (64950-345-16) 473 ml 2024-07-15 No No Current