FDA.reportPublic FDA data

Immunies

Product NDC
80353-196
11-digit product format
803530196
Labeler code
80353
Product ID
80353-196_4e3b040e-367f-a571-e063-6394a90a89d5
Type
HUMAN OTC DRUG
Nonproprietary name
Homeopathic Immunomodulator
Dosage form
CAPSULE
Route
ORAL
Labeler
HCBIOPHARM LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-10-20
Substance
PANAX GINSENG WHOLE
Active strength
1 [hp_X]/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANAX GINSENG WHOLE1 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9L5JEP7MESInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce47503f-0c5a-5bb7-e053-2995a90a9d43Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80353-196-01Immunies1 in 1 BOXCAPSULE17
80353-196-02Immunies1 in 1 BOTTLE, GLASSCAPSULE17
80353-196-03Immunies54 in 1 CAPSULECAPSULE547

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80353-196IMMUNIES (HOMEOPATHIC IMMUNOMODULATOR) CAPSULE [HCBIOPHARM LLC]6Current NDC, Legacy NDC, 3 package rows20250104_ce47503f-0c5a-5bb7-e053-2995a90a9d43.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
ImmuniesHOMEOPATHIC IMMUNOMODULATORHCBIOPHARM LLCce47503f-0c5a-5bb7-e053-2995a90a9d432026-03-30WarningsExact identifier
ndc (product): 80353-196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80353-196-01803530196011 BOTTLE, GLASS in 1 BOX (80353-196-01) / 1 CAPSULE in 1 BOTTLE, GLASS (80353-196-02) / 54 CAPSULE in 1 CAPSULE (80353-196-03) 2021-10-200000-00-00NoNoCurrent
80353-196-02803530196021 in 1 BOTTLE, GLASSHistorical
80353-196-038035301960354 in 1 CAPSULEHistorical