FDA.reportPublic FDA data

Promethazine and Phenylephrine HCl, and Codeine Phosphate

Product NDC
65162-694
11-digit product format
651620694
Labeler code
65162
Product ID
65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine, Phenylephrine, Codeine
Dosage form
SYRUP
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA200963
Marketing category
ANDA
Marketing start
2013-11-01
Substance
PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active strength
6.25; 5; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
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
A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATECODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200963-001AA

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 22:38:342026-08A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-2684e616aacf4f…
2026-08-18 06:07:402026-07A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-263f01610625f2…
2019-09-15 20:21 UTC2019-09A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200963-001PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE10MG/5ML;5MG/5ML;6.25MG/5MLSYRUP / ORALAA2015-08-26f41ea6bd6efb…

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 22:38:342026-08A200963-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A200963-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200963-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200963-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200963-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200963-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200963-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200963-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200963-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200963-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200963-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200963-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200963-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200963-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200963-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200963-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200963-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200963-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200963-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200963-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200963-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200963-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200963-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A200963-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200963-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200963-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200963-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A200963-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200963-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200963-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200963-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200963-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200963-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200963-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200963-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200963-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200963-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200963-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200963-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200963-001AA1f41ea6bd6efb…

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 and Phenylephrine HCl, and Codeine Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL
CODEINE PHOSPHATE10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R61ZEH7I1IInternal UNII lookup
04JA59TNSJInternal UNII lookup
GSL05Y1MN6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996757Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f23b254-872b-4e88-91be-710c3ea7687bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-694-86Promethazine and Phenylephrine HCl, and Codeine Phosphate118 mL in 1 BOTTLESYRUP11836
65162-694-90Promethazine and Phenylephrine HCl, and Codeine Phosphate473 mL in 1 BOTTLESYRUP47336

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-694-86ML - Milliliter65162-694efd83745-816f-432a-80bb-3d7c8b796a0612016-02-04
65162-694-90ML - Milliliter65162-69486f9d325-8a98-4027-ad06-3253a0421fa312016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SODIUM CITRATE, UNSPECIFIED FORMINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-694PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS LLC]30Current NDC, Legacy NDC, 2 package rows20240215_5f23b254-872b-4e88-91be-710c3ea7687b.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 and Phenylephrine HCl, and Codeine PhosphatePROMETHAZINE, PHENYLEPHRINE, CODEINEAmneal Pharmaceuticals LLC5f23b254-872b-4e88-91be-710c3ea7687b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200963
application number: ANDA200963
ndc (product): 65162-694

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996757codeine phosphate 10 MG / phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN5f23b254-872b-4e88-91be-710c3ea7687b36
996757codeine phosphate 2 MG/ML / phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD5f23b254-872b-4e88-91be-710c3ea7687b36
996757codeine phosphate 10 MG / phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSY5f23b254-872b-4e88-91be-710c3ea7687b36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-694-8665162069486118 mL in 1 BOTTLE (65162-694-86) 118 ml2013-11-010000-00-00NoNoCurrent
65162-694-9065162069490473 mL in 1 BOTTLE (65162-694-90) 473 ml2013-11-010000-00-00NoNoCurrent