Promethazine VC with Codeine Oral Solution

Product NDC
0121-0925
11-digit product format
001210925
Labeler code
0121
Product ID
0121-0925_bdd6aba3-0504-a99b-e053-2995a90a6467
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA040660
Marketing category
ANDA
Marketing start
2021-03-18
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0121-0925DDiscontinued by firm2026-10-05
excluded packagepackage0121-09250121-0925-16DDiscontinued by firm2026-10-05

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0121-0925DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-09250121-0925-16DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATECODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040660-001AA

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-0784e616aacf4f…
2026-08-18 06:07:402026-07A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2006-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040660-001PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAARS2006-12-07f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040660-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A040660-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040660-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040660-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040660-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040660-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040660-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040660-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040660-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040660-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040660-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040660-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040660-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040660-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040660-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040660-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040660-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040660-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040660-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040660-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040660-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040660-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040660-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040660-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040660-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040660-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040660-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040660-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040660-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040660-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040660-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040660-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040660-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040660-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040660-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040660-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040660-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040660-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040660-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040660-001AA1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0925-16ML - Milliliter0121-09258bb38d72-aefc-4d72-a0fe-1a11b931ce4012021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0925PROMETHAZINE VC WITH CODEINE ORAL SOLUTION (PROMETHAZINE AND PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [PAI HOLDINGS, LLC]4Legacy NDC20240131_75c68c3a-8d8d-4a13-87de-3eb73608c943.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0925-1600121092516473 mL in 1 BOTTLE (0121-0925-16) 473 ml2021-03-180000-00-00NoNoCurrent