FDA.reportPublic FDA data

Phenohytro

Product NDC
17856-0125
Requested package NDC
17856-0125-1
11-digit product format
178560125
Labeler code
17856
Product ID
17856-0125_5230a82a-5a35-c03e-e063-6294a90aa754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide
Dosage form
ELIXIR
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-30
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
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Additional Listing Data#

Finished product
Yes
Brand name base
Phenohytro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL.0194 mg/5mL
HYOSCYAMINE SULFATE.1037 mg/5mL
ATROPINE SULFATE16.2 mg/5mL
SCOPOLAMINE HYDROBROMIDE.0065 mg/5mL

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
1046787Internal RxNorm lookup
2048017Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5aaf1db-1938-4073-9da4-c47f959d013eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-0125-12024-04-08PHENOHYTRO ® ELIXIR
17856-0125-22024-04-08PHENOHYTRO ® ELIXIR
17856-0125-12024-01-30PHENOHYTRO ® ELIXIR
17856-0125-22024-01-30PHENOHYTRO ® ELIXIR
17856-0125-12022-09-27PHENOHYTRO ® ELIXIR
17856-0125-22022-09-27PHENOHYTRO ® ELIXIR
17856-0125-12022-01-28PHENOHYTRO ® ELIXIR
17856-0125-22022-01-28PHENOHYTRO ® ELIXIR
17856-0125-12020-05-20PHENOHYTRO ® ELIXIR
17856-0125-22020-05-20PHENOHYTRO ® ELIXIR
17856-0125-12020-01-31PHENOHYTRO ® ELIXIR
17856-0125-22020-01-31PHENOHYTRO ® ELIXIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0125-1Phenohytro72 in 1 BOXELIXIR727
17856-0125-2Phenohytro72 in 1 BOXELIXIR727
17856-0125-3Phenohytro10 mL in 1 CUP, UNIT-DOSEELIXIR107
17856-0125-4Phenohytro5 mL in 1 CUP, UNIT-DOSEELIXIR57
17856-0125-5Phenohytro45 in 1 CASEELIXIR457
17856-0125-5Phenohytro5 mL in 1 SYRINGEELIXIR57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0125-1ML - Milliliter17856-01252ed264d8-f8ea-459f-a747-ad4897052c1812020-09-14
17856-0125-2ML - Milliliter17856-0125cf5e4935-dff7-4c8e-a07c-708bf81423be12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0125PHENOHYTRO (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE) ELIXIR [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 6 package rows20250524_a5aaf1db-1938-4073-9da4-c47f959d013e.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, AND SCOPOLAMINE HYDROBROMIDEATLANTIC BIOLOGICALS CORP.a5aaf1db-1938-4073-9da4-c47f959d013e2026-05-19Warnings, Adverse reactionsExact identifier
ndc (package): 17856-0125-1
ndc (product): 17856-0125
ndc11 (package): 17856012501

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 SolutionPSNa5aaf1db-1938-4073-9da4-c47f959d013e7
2048017Phenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral SolutionPSNa5aaf1db-1938-4073-9da4-c47f959d013e7
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]SBDa5aaf1db-1938-4073-9da4-c47f959d013e7
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCDa5aaf1db-1938-4073-9da4-c47f959d013e7
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSYa5aaf1db-1938-4073-9da4-c47f959d013e7
2048017Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral SolutionSYa5aaf1db-1938-4073-9da4-c47f959d013e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0125-11785601250172 CUP, UNIT-DOSE in 1 BOX (17856-0125-1) / 10 mL in 1 CUP, UNIT-DOSE (17856-0125-3) 2024-04-080000-00-00NoNoCurrent