FDA.reportPublic FDA data

Biotitum

Manufacturer
Hahnemann Laboratories, INC.
Effective date
2022-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:24

Label at a glance#

ProductBiotitum
Active ingredientBIOTIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biotitum 6C 5gBiotitum 6C 5gBiotitum 6C 30gBiotitum 6C 30gBiotitum 6C 100gBiotitum 6C 100gBiotitum 12C 5gBiotitum 12C 5gBiotitum 12C 30gBiotitum 12C 30gBiotitum 12C 100gBiotitum 12C 100gBiotitum 30C 1gBiotitum 30C 1gBiotitum 30C 5gBiotitum 30C 5gBiotitum 30C 30gBiotitum 30C 30gBiotitum 30C 100gBiotitum 30C 100gBiotitum 100C 1gBiotitum 100C 1gBiotitum 100C 5gBiotitum 100C 5gBiotitum 100C 30gBiotitum 100C 30gBiotitum 100C 100gBiotitum 100C 100gBiotitum 200C 1gBiotitum 200C 1gBiotitum 200C 5gBiotitum 200C 5gBiotitum 200C 30gBiotitum 200C 30gBiotitum 200C 100gBiotitum 200C 100gBiotitum 500C 1gBiotitum 500C 1gBiotitum 500C 5gBiotitum 500C 5gBiotitum 500C 30gBiotitum 500C 30gBiotitum 500C 100gBiotitum 500C 100gBiotitum 1M 1gBiotitum 1M 1gBiotitum 1M 5gBiotitum 1M 5gBiotitum 1M 30gBiotitum 1M 30gBiotitum 1M 100gBiotitum 1M 100gBiotitum LM1 30gBiotitum LM1 30g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63545-630-01Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-630-02Biotitum1200 in 1 BOTTLE, GLASSPELLET12001
63545-630-03Biotitum4000 in 1 BOTTLE, GLASSPELLET40001
63545-631-01Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-631-02Biotitum1200 in 1 BOTTLE, GLASSPELLET12001
63545-631-03Biotitum4000 in 1 BOTTLE, GLASSPELLET40001
63545-632-01Biotitum80 in 1 VIAL, GLASSPELLET801
63545-632-02Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-632-03Biotitum1200 in 1 BOTTLE, GLASSPELLET12001
63545-632-04Biotitum4000 in 1 BOTTLE, GLASSPELLET40001
63545-633-01Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-633-02Biotitum500 in 1 VIAL, GLASSPELLET5001
63545-633-03Biotitum3000 in 1 BOTTLE, GLASSPELLET30001
63545-633-04Biotitum10000 in 1 BOTTLE, GLASSPELLET100001
63545-634-01Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-634-02Biotitum500 in 1 VIAL, GLASSPELLET5001
63545-634-03Biotitum3000 in 1 BOTTLE, GLASSPELLET30001
63545-634-04Biotitum10000 in 1 BOTTLE, GLASSPELLET100001
63545-635-01Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-635-02Biotitum500 in 1 VIAL, GLASSPELLET5001
63545-635-03Biotitum3000 in 1 BOTTLE, GLASSPELLET30001
63545-635-04Biotitum10000 in 1 BOTTLE, GLASSPELLET100001
63545-636-01Biotitum200 in 1 VIAL, GLASSPELLET2001
63545-636-02Biotitum500 in 1 VIAL, GLASSPELLET5001
63545-636-03Biotitum3000 in 1 BOTTLE, GLASSPELLET30001
63545-636-04Biotitum10000 in 1 BOTTLE, GLASSPELLET100001
63545-638-01Biotitum10000 in 1 BOTTLE, GLASSPELLET100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63545-630BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip
63545-631BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip
63545-632BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip
63545-633BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip
63545-634BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip
63545-635BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip
63545-636BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip
63545-638BIOTITUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20220510_de9c9f85-221a-18d2-e053-2a95a90a3c69.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63545-63063545-630-01, 63545-630-02, 63545-630-03
63545-63163545-631-01, 63545-631-02, 63545-631-03
63545-63263545-632-01, 63545-632-02, 63545-632-03, 63545-632-04
63545-63363545-633-01, 63545-633-02, 63545-633-03, 63545-633-04
63545-63463545-634-01, 63545-634-02, 63545-634-03, 63545-634-04
63545-63563545-635-01, 63545-635-02, 63545-635-03, 63545-635-04
63545-63663545-636-01, 63545-636-02, 63545-636-03, 63545-636-04
63545-63863545-638-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT
BIOTIN6SO6U10H04ACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

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
BiotitumBIOTITUMHahnemann Laboratories, INC.de9c9f85-221a-18d2-e053-2a95a90a3c692022-05-09Exact identifier
ndc (package): 63545-631-01
ndc (package): 63545-635-03
ndc (package): 63545-636-04
ndc (package): 63545-632-04
ndc (package): 63545-634-04
ndc (package): 63545-630-03
ndc (package): 63545-632-02
ndc (package): 63545-631-03
ndc (package): 63545-630-02
ndc (package): 63545-632-03
ndc (package): 63545-630-01
ndc (package): 63545-633-03
ndc (package): 63545-636-01
ndc (package): 63545-636-03
ndc (package): 63545-635-02
ndc (package): 63545-634-03
ndc (package): 63545-632-01
ndc (package): 63545-634-02
ndc (package): 63545-636-02
ndc (package): 63545-633-01
ndc (package): 63545-633-02
ndc (package): 63545-633-04
ndc (package): 63545-638-01
ndc (package): 63545-635-04
ndc (package): 63545-635-01
ndc (package): 63545-634-01
ndc (package): 63545-631-02
ndc (product): 63545-630
ndc (product): 63545-638
ndc (product): 63545-633
ndc (product): 63545-635
ndc (product): 63545-636
ndc (product): 63545-632
ndc (product): 63545-634
ndc (product): 63545-631
ndc11 (package): 63545063203
ndc11 (package): 63545063602
ndc11 (package): 63545063204
ndc11 (package): 63545063504
ndc11 (package): 63545063601
ndc11 (package): 63545063404
ndc11 (package): 63545063502
ndc11 (package): 63545063302
ndc11 (package): 63545063001
ndc11 (package): 63545063003
ndc11 (package): 63545063801
ndc11 (package): 63545063101
ndc11 (package): 63545063501
ndc11 (package): 63545063103
ndc11 (package): 63545063002
ndc11 (package): 63545063201
ndc11 (package): 63545063301
ndc11 (package): 63545063304
ndc11 (package): 63545063503
ndc11 (package): 63545063402
ndc11 (package): 63545063403
ndc11 (package): 63545063603
ndc11 (package): 63545063202
ndc11 (package): 63545063604
ndc11 (package): 63545063401
ndc11 (package): 63545063102
ndc11 (package): 63545063303
spl id: de9c9f85-221b-18d2-e053-2a95a90a3c69
spl set id: de9c9f85-221a-18d2-e053-2a95a90a3c69

Reported adverse events (FAERS/openFDA)#

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