FDA.reportPublic FDA data

Phenohytro

Product NDC
75826-118
11-digit product format
758260118
Labeler code
75826
Product ID
75826-118_2b37a6e2-6e67-1233-e063-6294a90a26ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Winder Laboratories, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-02-29
Substance
ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength
.0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1
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
PHENOBARBITAL.0194 mg/1
HYOSCYAMINE SULFATE.1037 mg/1
ATROPINE SULFATE16.2 mg/1
SCOPOLAMINE HYDROBROMIDE.0065 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YQE403BP4DInternal UNII lookup
F2R8V82B84Internal UNII lookup
03J5ZE7KA5Internal UNII lookup
451IFR0GXBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046815Internal RxNorm lookup
1739887Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27c8baac-f8ce-46d8-8a0f-ff769dd408d9Available on FDA.report

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
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75826-118-00Phenohytro1000 in 1 BOTTLE, PLASTICTABLET10005
75826-118-10Phenohytro100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75826-118-10EA - Each75826-118978d16e6-2d08-4274-b8c0-8f30eea29c8812016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-118PHENOHYTRO (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [WINDER LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20250110_27c8baac-f8ce-46d8-8a0f-ff769dd408d9.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
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEWinder Laboratories, LLC27c8baac-f8ce-46d8-8a0f-ff769dd408d92019-12-27Warnings, Adverse reactionsExact identifier
ndc (product): 75826-118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG Oral TabletPSN27c8baac-f8ce-46d8-8a0f-ff769dd408d95
1739887Phenohytro 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral TabletPSN27c8baac-f8ce-46d8-8a0f-ff769dd408d95
1739887atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Phenohytro]SBD27c8baac-f8ce-46d8-8a0f-ff769dd408d95
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral TabletSCD27c8baac-f8ce-46d8-8a0f-ff769dd408d95
1739887Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) Oral TabletSY27c8baac-f8ce-46d8-8a0f-ff769dd408d95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75826-118-00758260118001000 TABLET in 1 BOTTLE, PLASTIC (75826-118-00) 1000 tablet2016-02-290000-00-00NoNoCurrent
75826-118-1075826011810100 TABLET in 1 BOTTLE, PLASTIC (75826-118-10) 100 tablet2016-02-290000-00-00NoNoCurrent