Promethazine Hydrochloride and Phenylephrine Hydrochloride

Product NDC
65162-679
Requested package NDC
65162-679-90
11-digit product format
651620679
Labeler code
65162
Product ID
65162-679_1cd384c6-b844-40d6-84bf-cdea9bbd334a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine and Phenylephrine
Dosage form
SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA040902
Marketing category
ANDA
Marketing start
2009-08-25
Substance
PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
6.25; 5 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 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
A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040902-001AA

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 22:38:342026-08A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-2584e616aacf4f…
2026-08-18 06:07:402026-07A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040902-001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE5MG/5ML;6.25MG/5MLSYRUP / ORALAA2009-08-25f41ea6bd6efb…

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 22:38:342026-08A040902-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A040902-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040902-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040902-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040902-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040902-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040902-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040902-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040902-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040902-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040902-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040902-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040902-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040902-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040902-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040902-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040902-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040902-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040902-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040902-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040902-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040902-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040902-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040902-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040902-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040902-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040902-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040902-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040902-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040902-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040902-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040902-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040902-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040902-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040902-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040902-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040902-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040902-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040902-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040902-001AA1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride and Phenylephrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R61ZEH7I1IInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1248057Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-679-86Promethazine Hydrochloride and Phenylephrine Hydrochloride118 mL in 1 BOTTLESOLUTION11812
65162-679-90Promethazine Hydrochloride and Phenylephrine Hydrochloride473 mL in 1 BOTTLESOLUTION47312

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-679PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (PROMETHAZINE AND PHENYLEPHRINE) SOLUTION [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 2 package rows20241031_cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine Hydrochloride and Phenylephrine HydrochloridePROMETHAZINE AND PHENYLEPHRINEAmneal Pharmaceuticals LLCcf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed42024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040902
application number: ANDA040902
ndc (package): 65162-679-90
ndc (product): 65162-679
ndc11 (package): 65162067990

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248057phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNcf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed412
1248057phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDcf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed412
1248057phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSYcf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-679-9065162067990473 mL in 1 BOTTLE (65162-679-90) 473 ml2009-08-250000-00-00NoNoCurrent