FDA.reportPublic FDA data

atropine 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]

RxCUI
2048017
RxNorm name
atropine 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]
Display name
PHENOHYTRO (Oral Liquid)
Full name
atropine 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]
Term type
SBD
Status
Active
Strength
0.0194-0.1035-16.2-0.0065 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-11-08 10:04:42

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
082018
Active start
082018
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
atropine sulfate0.00388 MG / 1 MLatropineatropine sulfate
hyoscyamine sulfate0.0207 MG / 1 MLhyoscyaminehyoscyamine sulfate
phenobarbital3.24 MG / 1 MLphenobarbitalphenobarbital
scopolamine hydrobromide0.0013 MG / 1 MLscopolaminescopolamine hydrobromide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
atropine1223
hyoscyamine153970
phenobarbital8134
scopolamine9601

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRPhenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral Solution1NAMES
RxNorm Nameatropine 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]1NAMES
RxNorm SynonymPhenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral Solution1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI20480171CODES
MMSL_CODEBD8401CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
17856-0125-117856-0125Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine HydrobromideATLANTIC BIOLOGICALS CORP.
17856-0125-217856-0125Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine HydrobromideATLANTIC BIOLOGICALS CORP.
17856-0125-517856-0125Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine HydrobromideATLANTIC BIOLOGICALS CORP.
75826-127-0475826-127Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine HydrobromideWinder Laboratories LLC
75826-127-1675826-127Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine HydrobromideWinder Laboratories LLC
75826-128-0475826-128Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine HydrobromideWinder Laboratories LLC
75826-128-1675826-128Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine HydrobromideWinder Laboratories LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 12 matching rows.

NDC11, Source, Active table
NDC11SourceActive
17856012501rxnav_ndcsyes
17856012502rxnav_ndcsyes
17856012503rxnav_ndcsyes
17856012504rxnav_ndcsyes
17856012505rxnav_ndcsyes
75826012704rxnav_ndcsyes
75826012716rxnav_ndcsyes
75826012804rxnav_ndcsyes
75826012816rxnav_ndcsyes
17856012301rxnav_historical
17856012302rxnav_historical
21695097016rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDEATLANTIC BIOLOGICALS CORP.a5aaf1db-1938-4073-9da4-c47f959d013e2026-05-19Warnings, Adverse reactionsExact identifier
ndc (package): 17856-0125-1
ndc (package): 17856-0125-5
ndc (package): 17856-0125-2
ndc (product): 17856-0125
ndc11 (package): 17856012505
ndc11 (package): 17856012501
ndc11 (package): 17856012502
ndc11 (package): 17856012503
ndc11 (package): 17856012504
rxcui: 2048017
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDEWinder Laboratories LLC29be31ef-108e-4b45-9ecc-b6d671da28262019-10-04Warnings, Adverse reactionsExact identifier
ndc (package): 75826-127-16
ndc (package): 75826-127-04
ndc (package): 75826-128-04
ndc (package): 75826-128-16
ndc (product): 75826-128
ndc (product): 75826-127
ndc11 (package): 75826012704
ndc11 (package): 75826012804
ndc11 (package): 75826012816
ndc11 (package): 75826012716
rxcui: 2048017

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a5aaf1db-1938-4073-9da4-c47f959d013ePhenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution [PSN] · atropine 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] [SBD] · Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral Solution [SY]37PHENOHYTRO ® ELIXIR20260519
29be31ef-108e-4b45-9ecc-b6d671da2826Phenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution [PSN] · atropine 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] [SBD] · Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral Solution [SY]34PHENOHYTRO ® ELIXIR20191004
d2c7febc-053e-4b22-9c99-af0e7fd9ce3fPhenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution [PSN] · atropine 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] [SBD] · Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral Solution [SY]32PHENOHYTRO ® ELIXIR20210112

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
a5aaf1db-1938-4073-9da4-c47f959d013ePHENOHYTRO ® ELIXIRATLANTIC BIOLOGICALS CORP.20260519
a5aaf1db-1938-4073-9da4-c47f959d013ePHENOHYTRO ® ELIXIRATLANTIC BIOLOGICALS CORP.20250922
d2c7febc-053e-4b22-9c99-af0e7fd9ce3fPHENOHYTRO ® ELIXIRATLANTIC BIOLOGICALS CORP.20210112
29be31ef-108e-4b45-9ecc-b6d671da2826PHENOHYTRO ® ELIXIRWinder Laboratories LLC | WINDER LABORATORIES, LLC20191004
ea5d8133-66ca-46a4-b00c-61fff85bc623National Council for Prescription Drug Programs20120724
6243f28a-e7ed-4571-beb3-2562c5e033c7QUADRAPAX ELIXIRRebel Distributors Corp20110913

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01FAAnticholinergicsATC1-4scopolamine
ATCS01FAAnticholinergicsATC1-4atropine
ATCN03AABarbiturates and derivativesATC1-4phenobarbital
ATCA03BABelladonna alkaloids, tertiary aminesATC1-4atropine
ATCA03BABelladonna alkaloids, tertiary aminesATC1-4hyoscyamine
ATCA04ADOther antiemeticsATC1-4scopolamine
ATCN05CMOther hypnotics and sedativesATC1-4scopolamine
FDASPLN0000175574AnticholinergicEPChas_epcscopolamine
FDASPLN0000175574AnticholinergicEPChas_epcatropine
FDASPLN0000175700Cholinergic Muscarinic AntagonistEPChas_epcatropine
FDASPLN0000175370Cholinergic AntagonistsMOAhas_moaatropine
FDASPLN0000175370Cholinergic AntagonistsMOAhas_moascopolamine
FDASPLN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine sulfate
MEDRTD064692HyoscyamineCHEMhas_ingredienthyoscyamine
MEDRTD064692HyoscyamineCHEMhas_ingredienthyoscyamine sulfate
MEDRTD010634PhenobarbitalCHEMhas_ingredientphenobarbital
MEDRTD012601ScopolamineCHEMhas_ingredientscopolamine
MEDRTD012601ScopolamineCHEMhas_ingredientscopolamine hydrobromide
MEDRTD000014Abnormalities, Drug-InducedDISEASEmay_treathyoscyamine sulfate
MEDRTD000014Abnormalities, Drug-InducedDISEASEmay_treathyoscyamine
MEDRTD000402Airway ObstructionDISEASEci_withphenobarbital
MEDRTD000647AmnesiaDISEASEinducesscopolamine
MEDRTD000647AmnesiaDISEASEinducesscopolamine hydrobromide
MEDRTD001249AsthmaDISEASEci_withatropine
MEDRTD001249AsthmaDISEASEci_withatropine sulfate
MEDRTD001919BradycardiaDISEASEmay_treatatropine sulfate
MEDRTD001919BradycardiaDISEASEmay_treatatropine
MEDRTD003085ColicDISEASEmay_treathyoscyamine
MEDRTD003085ColicDISEASEmay_treathyoscyamine sulfate
MEDRTD003093Colitis, UlcerativeDISEASEci_withhyoscyamine
MEDRTD003093Colitis, UlcerativeDISEASEci_withhyoscyamine sulfate
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine sulfate
MEDRTD003108Colonic DiseasesDISEASEmay_treatscopolamine
MEDRTD003108Colonic DiseasesDISEASEmay_treatscopolamine hydrobromide
MEDRTD004238DiverticulitisDISEASEmay_treatscopolamine hydrobromide
MEDRTD004238DiverticulitisDISEASEmay_treatscopolamine
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withphenobarbital
MEDRTD004342Drug HypersensitivityDISEASEci_withscopolamine
MEDRTD004342Drug HypersensitivityDISEASEci_withscopolamine hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withhyoscyamine
MEDRTD004342Drug HypersensitivityDISEASEci_withhyoscyamine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine sulfate
MEDRTD004403DysenteryDISEASEmay_treatscopolamine
MEDRTD004403DysenteryDISEASEmay_treatscopolamine hydrobromide
MEDRTD004828Epilepsies, PartialDISEASEmay_treatphenobarbital
MEDRTD020936Epilepsy, Benign NeonatalDISEASEmay_treatphenobarbital
MEDRTD004830Epilepsy, Tonic-ClonicDISEASEmay_treatphenobarbital
MEDRTD005158Facial ParalysisDISEASEmay_treatscopolamine
MEDRTD005158Facial ParalysisDISEASEmay_treatscopolamine hydrobromide
MEDRTD018589GastroparesisDISEASEinduceshyoscyamine sulfate
MEDRTD018589GastroparesisDISEASEinduceshyoscyamine
MEDRTD005901GlaucomaDISEASEci_withhyoscyamine
MEDRTD005901GlaucomaDISEASEci_withhyoscyamine sulfate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withscopolamine hydrobromide
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withscopolamine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine sulfate
MEDRTD006323Heart ArrestDISEASEmay_treatatropine sulfate
MEDRTD006323Heart ArrestDISEASEmay_treatatropine
MEDRTD006327Heart BlockDISEASEci_withatropine
MEDRTD006327Heart BlockDISEASEci_withatropine sulfate
MEDRTD006470HemorrhageDISEASEci_withscopolamine
MEDRTD006470HemorrhageDISEASEci_withscopolamine hydrobromide
MEDRTD006932HyperbilirubinemiaDISEASEmay_treatphenobarbital
MEDRTD006945HyperhidrosisDISEASEmay_treathyoscyamine sulfate
MEDRTD006945HyperhidrosisDISEASEmay_treathyoscyamine
MEDRTD007077Ileal DiseasesDISEASEci_withhyoscyamine sulfate
MEDRTD007077Ileal DiseasesDISEASEci_withhyoscyamine
MEDRTD007415Intestinal ObstructionDISEASEci_withhyoscyamine sulfate
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine
MEDRTD007415Intestinal ObstructionDISEASEci_withhyoscyamine
MEDRTD007415Intestinal ObstructionDISEASEci_withscopolamine
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine sulfate
MEDRTD007415Intestinal ObstructionDISEASEci_withscopolamine hydrobromide
MEDRTD007431Intraoperative ComplicationsDISEASEmay_treathyoscyamine sulfate
MEDRTD007431Intraoperative ComplicationsDISEASEmay_treathyoscyamine
MEDRTD015863IridocyclitisDISEASEmay_treatscopolamine
MEDRTD015863IridocyclitisDISEASEmay_treatscopolamine hydrobromide
MEDRTD007499Iris DiseasesDISEASEci_withatropine
MEDRTD007499Iris DiseasesDISEASEci_withatropine sulfate
MEDRTD043183Irritable Bowel SyndromeDISEASEmay_treathyoscyamine
MEDRTD043183Irritable Bowel SyndromeDISEASEmay_treathyoscyamine sulfate
MEDRTD007674Kidney DiseasesDISEASEci_withatropine
MEDRTD007674Kidney DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withatropine sulfate
MEDRTD017093Liver FailureDISEASEci_withphenobarbital
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine sulfate
MEDRTD008532Megacolon, ToxicDISEASEci_withhyoscyamine sulfate
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine
MEDRTD008532Megacolon, ToxicDISEASEci_withhyoscyamine
MEDRTD009041Motion SicknessDISEASEmay_preventscopolamine hydrobromide
MEDRTD009041Motion SicknessDISEASEmay_preventscopolamine
MEDRTD009127Muscle RigidityDISEASEmay_treathyoscyamine sulfate
MEDRTD009127Muscle RigidityDISEASEmay_treathyoscyamine
MEDRTD009157Myasthenia GravisDISEASEci_withatropine
MEDRTD009157Myasthenia GravisDISEASEci_withhyoscyamine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withscopolamine
MEDRTD009157Myasthenia GravisDISEASEci_withatropine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withhyoscyamine
MEDRTD009157Myasthenia GravisDISEASEci_withscopolamine hydrobromide
MEDRTD015878MydriasisDISEASEinducesscopolamine hydrobromide
MEDRTD015878MydriasisDISEASEinducesscopolamine
MEDRTD015878MydriasisDISEASEinducesatropine
MEDRTD015878MydriasisDISEASEinducesatropine sulfate
MEDRTD017202Myocardial IschemiaDISEASEci_withhyoscyamine
MEDRTD017202Myocardial IschemiaDISEASEci_withhyoscyamine sulfate
MEDRTD009325NauseaDISEASEmay_preventscopolamine hydrobromide
MEDRTD009325NauseaDISEASEmay_preventscopolamine
MEDRTD010301Parkinson Disease, PostencephaliticDISEASEmay_treatscopolamine
MEDRTD010301Parkinson Disease, PostencephaliticDISEASEmay_treatscopolamine hydrobromide
MEDRTD010437Peptic UlcerDISEASEmay_treathyoscyamine sulfate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.00388 MG/ML / 0.0207 MG/ML / 3.24 MG/ML / 0.0013 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE4
NAMESPrescribable SynonymPhenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution
NAMESTallman Synonymatropine 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]
NAMESTallman SynonymPhenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon