FDA.reportPublic FDA data

Phenohytro

Product NDC
75826-128
11-digit product format
758260128
Labeler code
75826
Product ID
75826-128_2b37aeea-56b7-fb21-e063-6294a90ad79b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide
Dosage form
ELIXIR
Route
ORAL
Labeler
Winder Laboratories LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-06-25
Substance
ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength
.0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenohytro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.0194 mg/5mL
HYOSCYAMINE SULFATE.1037 mg/5mL
PHENOBARBITAL16.2 mg/5mL
SCOPOLAMINE HYDROBROMIDE.0065 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D, 03J5ZE7KA5, F2R8V82B84, 451IFR0GXB
Rxcui1046787, 2048017

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75826-128-04Phenohytro118 mL in 1 BOTTLE, PLASTICELIXIR1184
75826-128-16Phenohytro473 mL in 1 BOTTLE, PLASTICELIXIR4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75826-128-04ML - Milliliter75826-128613e03e0-1816-4b68-956e-da3afa81789412018-07-03
75826-128-16ML - Milliliter75826-1285e3689e7-3374-4fa4-827a-3e6f704bdb8212018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-128PHENOHYTRO (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE) ELIXIR [WINDER LABORATORIES LLC]4Current NDC, Legacy NDC, 2 package rows20250110_29be31ef-108e-4b45-9ecc-b6d671da2826.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046787PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral SolutionPSN29be31ef-108e-4b45-9ecc-b6d671da28264
2048017Phenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral SolutionPSN29be31ef-108e-4b45-9ecc-b6d671da28264
2048017atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Phenohytro]SBD29be31ef-108e-4b45-9ecc-b6d671da28264
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCD29be31ef-108e-4b45-9ecc-b6d671da28264
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSY29be31ef-108e-4b45-9ecc-b6d671da28264
2048017Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral SolutionSY29be31ef-108e-4b45-9ecc-b6d671da28264
1046787PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral SolutionPSNd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
2048017Phenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral SolutionPSNd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
2048017atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Phenohytro]SBDd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCDd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSYd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
2048017Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral SolutionSYd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75826-128-0475826012804118 mL in 1 BOTTLE, PLASTIC (75826-128-04) 118 ml2018-06-250000-00-00NoNoCurrent
75826-128-1675826012816473 mL in 1 BOTTLE, PLASTIC (75826-128-16) 473 ml2018-06-250000-00-00NoNoCurrent