Home NDC 68788-6763 Promethazine VC
Product NDC 68788-6763
11-digit product format 687886763
Labeler code 68788
Product ID 68788-6763_7c7443de-ad12-45f5-b439-c668ab5ae9fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazinehydrochloride and phenylephrine hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA040654
Marketing category ANDA
Marketing start 2012-07-25
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 E
Listing certified through 2017-12-31
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68788-6763-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68788-6763-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68788-6763-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68788-6763-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68788-6763-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68788-6763-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68788-6763-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68788-6763-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-6763-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68788-6763-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68788-6763-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68788-6763-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68788-6763-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68788-6763-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE VC (PROMETHAZINEHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PREFERRED PHARMACEUTICALS, INC.] 2
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.