FDA.reportPublic FDA data

Phenobarbital

Product NDC
69367-367
Requested package NDC
69367-367-16
11-digit product format
693670367
Labeler code
69367
Product ID
69367-367_cf0962ad-4f57-4733-a836-844ac7764a01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
ELIXIR
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-05-01
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Phenobarbital
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL20 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YQE403BP4DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87148299-a3a6-40af-afa6-f32ac2f678c6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-367-16Phenobarbital473 mL in 1 BOTTLE, PLASTICELIXIR4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-367-16ML - Milliliter69367-36773b619fc-8fd1-4aaa-ab33-bf2b1563eb6512025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-367PHENOBARBITAL ELIXIR [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20250511_87148299-a3a6-40af-afa6-f32ac2f678c6.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
PhenobarbitalPHENOBARBITALWestminster Pharmaceuticals, LLC87148299-a3a6-40af-afa6-f32ac2f678c62025-05-08Warnings, Adverse reactionsExact identifier
ndc (package): 69367-367-16
ndc (product): 69367-367
ndc11 (package): 69367036716

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN87148299-a3a6-40af-afa6-f32ac2f678c61
702519phenobarbital 4 MG/ML Oral SolutionSCD87148299-a3a6-40af-afa6-f32ac2f678c61
702519phenobarbital 20 MG per 5 ML Oral SolutionSY87148299-a3a6-40af-afa6-f32ac2f678c61
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY87148299-a3a6-40af-afa6-f32ac2f678c61
702519phenobarbital 60 MG per 15 ML Oral SolutionSY87148299-a3a6-40af-afa6-f32ac2f678c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-367-1669367036716473 mL in 1 BOTTLE, PLASTIC (69367-367-16) 473 ml2025-05-01NoNoCurrent