PHENOBARBITAL

Product NDC: 58118-0572
Requested package NDC: 58118-0572-8
11-digit product format: 581180572
Labeler code: 58118
Product ID: 58118-0572_53fb86e0-6b10-5124-e063-6394a90af18f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENOBARBITAL
Dosage form: TABLET
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2025-03-01
Substance: PHENOBARBITAL
Active strength: 15 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENOBARBITAL	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YQE403BP4D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312357	Internal RxNorm lookup
312362	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
324fde5b-961f-438b-8d9c-b679511dd907	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENOBARBITAL	PHENOBARBITAL	Clinical Solutions Wholesale, LLC	324fde5b-961f-438b-8d9c-b679511dd907	2026-06-11	Warnings, Adverse reactions	Exact identifier ndc (package): 58118-0572-8 ndc (product): 58118-0572 ndc11 (package): 58118057208

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YQE403BP4D	PHENOBARBITAL	50-06-6	PHENOBARBITAL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58118-0572-8	58118057208	30 TABLET in 1 BLISTER PACK (58118-0572-8)	30 tablet	2026-06-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL TABLETS, USP CIV	Clinical Solutions Wholesale, LLC	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	1