FDA.reportPublic FDA data

Phenobarbital

Product NDC
13811-299
11-digit product format
138110299
Labeler code
13811
Product ID
13811-299_bcb25645-8c32-48a6-be08-1e6d72cc5c50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
ELIXIR
Route
ORAL
Labeler
Trigen Laboratories, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-05-05
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
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
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
057992c1-29a0-4229-9c30-d787cb632eacAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13811-299-08Phenobarbital473 mL in 1 BOTTLE, PLASTICELIXIR4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-299-08ML - Milliliter13811-2990e1737d7-ea7d-4e2d-affb-094b77f16bbb12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-299PHENOBARBITAL ELIXIR [TRIGEN LABORATORIES, LLC]1Current NDC, 1 package rows20250506_057992c1-29a0-4229-9c30-d787cb632eac.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
PhenobarbitalPHENOBARBITALTrigen Laboratories, LLC057992c1-29a0-4229-9c30-d787cb632eac2025-09-22Warnings, Adverse reactionsExact identifier
ndc (product): 13811-299

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 4 MG/ML Oral SolutionSCD057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 20 MG per 5 ML Oral SolutionSY057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 60 MG per 15 ML Oral SolutionSY057992c1-29a0-4229-9c30-d787cb632eac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13811-299-0813811029908473 mL in 1 BOTTLE, PLASTIC (13811-299-08) 473 ml2025-05-05NoNoCurrent