Home NDC 0121-0926-16 Promethazine VC
Product NDC 0121-0926
Requested package NDC 0121-0926-16
11-digit product format 001210926
Labeler code 0121
Product ID 0121-0926_bd449be1-5e7f-35a8-e053-2995a90a2e02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Phenylephrine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Pharmaceutical Associates, Inc.
Application ANDA040654
Marketing category ANDA
Marketing start 2021-03-11
Marketing end 0000-00-00
Substance PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 6 mg/5mL; mg/5mL
Pharmacologic classes Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 2 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 Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0121-0926 0121-0926-16 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0121-0926 0121-0926-16 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-0926-16 00121092616 437 mL in 1 BOTTLE (0121-0926-16) 437 ml 2021-03-11 0000-00-00 No No Current