FDA.reportPublic FDA data

Weight Off

Product NDC
83027-0028
11-digit product format
830270028
Labeler code
83027
Product ID
83027-0028_afbc28ff-8713-4ee5-970e-987407f0ff79
Type
HUMAN OTC DRUG
Nonproprietary name
Foeniculum Vulgare, Fucus Vesiculosus, Lecithin, Ammonium Carbonicum, Caulophyllum Thalictroides, Galium Aparine, Lac Defloratum (NSPC), Manganum Aceticum, Phytolacca Decandra, Rubus Idaeus, Thyroidinum (Bovine), Ammonium Bromatum, Antimonium Crudum, Calcarea Carbonica, Calcarea Arsenicica, Human Growth Hormone (HGH), Phosphorus
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-03-31
Substance
AMMONIUM BROMIDE; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; CALCIUM ARSENATE; CAULOPHYLLUM THALICTROIDES ROOT; EGG PHOSPHOLIPIDS; FOENICULUM VULGARE FRUIT; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; MANGANESE ACETATE TETRAHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; SKIM MILK; SOMATROPIN; THYROID, BOVINE
Active strength
8; 6; 9; 12; 6; 4; 2; 3; 6; 6; 9; 12; 6; 6; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Human Growth Hormone [CS], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC], Recombinant Human Growth Hormone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Weight Off
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOENICULUM VULGARE FRUIT8 [hp_X]/mL
FUCUS VESICULOSUS6 [hp_X]/mL
EGG PHOSPHOLIPIDS9 [hp_X]/mL
AMMONIUM CARBONATE12 [hp_X]/mL
CAULOPHYLLUM THALICTROIDES ROOT6 [hp_X]/mL
GALIUM APARINE WHOLE4 [hp_X]/mL
SKIM MILK2 [hp_X]/mL
MANGANESE ACETATE TETRAHYDRATE3 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/mL
RUBUS IDAEUS LEAF6 [hp_X]/mL
THYROID, BOVINE9 [hp_X]/mL
AMMONIUM BROMIDE12 [hp_X]/mL
ANTIMONY TRISULFIDE6 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE6 [hp_X]/mL
CALCIUM ARSENATE6 [hp_X]/mL
SOMATROPIN12 [hp_X]/mL
PHOSPHORUS6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 17 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J5W36Y5WG8Internal UNII lookup
535G2ABX9MInternal UNII lookup
1Z74184RGVInternal UNII lookup
NJ5VT0FKLJInternal UNII lookup
JTJ6HH6YEHInternal UNII lookup
Z4B6561488Internal UNII lookup
6A001Y4M5AInternal UNII lookup
9TO51D176NInternal UNII lookup
11E6VI8VEGInternal UNII lookup
8O2V33JG64Internal UNII lookup
MN18OTN73WInternal UNII lookup
R0JB3224WSInternal UNII lookup
F79059A38UInternal UNII lookup
2E32821G6IInternal UNII lookup
95OX15I8ZUInternal UNII lookup
NQX9KB6PCLInternal UNII lookup
27YLU75U4WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5506e6ab-0f0f-4ee6-9a5a-6eb937a457a1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0028-1Weight Off60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0028WEIGHT OFF (FOENICULUM VULGARE, FUCUS VESICULOSUS, LECITHIN, AMMONIUM CARBONICUM, CAULOPHYLLUM THALICTROIDES, GALIUM APARINE, LAC DEFLORATUM (NSPC), MANGANUM ACETICUM, PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), AMMONIUM BROMATUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, CALCAREA ARSENICICA, HUMAN GROWTH HORMONE (HGH), PHOSPHORUS) SPRAY [NUTRITIONAL SPECIALTIES, INC.]2Current NDC, 1 package rows20240725_5506e6ab-0f0f-4ee6-9a5a-6eb937a457a1.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
Weight OffFOENICULUM VULGARE, FUCUS VESICULOSUS, LECITHIN, AMMONIUM CARBONICUM, CAULOPHYLLUM THALICTROIDES, GALIUM APARINE, LAC DEFLORATUM (NSPC), MANGANUM ACETICUM, PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), AMMONIUM BROMATUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, CALCAREA ARSENICICA, HUMAN GROWTH HORMONE (HGH), PHOSPHORUSNutritional Specialties, Inc.5506e6ab-0f0f-4ee6-9a5a-6eb937a457a12024-07-24WarningsExact identifier
ndc (product): 83027-0028

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0028-18302700280160 mL in 1 BOTTLE, SPRAY (83027-0028-1) 60 ml2023-03-31NoNoCurrent