Body Balance

Product NDC
44911-0635
11-digit product format
449110635
Labeler code
44911
Product ID
44911-0635_a35365e2-3091-45cd-acde-e02a0b0a779a
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (Suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis
Dosage form
SPRAY
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-03-16
Substance
AVENA SATIVA FLOWERING TOP; BOS TAURUS HYPOTHALAMUS; CHLOROPHYTUM BORIVILIANUM WHOLE; DELPHINIUM STAPHISAGRIA SEED; NUPHAR LUTEA ROOT; PUNICA GRANATUM ROOT BARK; SELENIUM; SUS SCROFA TESTICLE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG
Active strength
3; 6; 3; 9; 6; 6; 9; 6; 12; 9 [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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Body Balance
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP3 [hp_X]/mL
CHLOROPHYTUM BORIVILIANUM WHOLE6 [hp_X]/mL
PUNICA GRANATUM ROOT BARK3 [hp_X]/mL
NUPHAR LUTEA ROOT9 [hp_X]/mL
BOS TAURUS HYPOTHALAMUS6 [hp_X]/mL
SUS SCROFA TESTICLE6 [hp_X]/mL
TURNERA DIFFUSA LEAFY TWIG9 [hp_X]/mL
SELENIUM6 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED12 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG9 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup
B0MD133CE7Internal UNII lookup
CLV24I3T1DInternal UNII lookup
714LIU3V6DInternal UNII lookup
S6G2NLH4Y7Internal UNII lookup
KM02613O28Internal UNII lookup
RQ2CFA7WWJInternal UNII lookup
H6241UJ22BInternal UNII lookup
00543AP1JVInternal UNII lookup
1NT28V9397Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8e70220-b3ef-4595-a8c3-a77a6bd373e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0635-12024-02-14C16284748780-1f386c64a-474f-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0635-12023-01-30C16284748780-1f386c64a-474f-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0635-1Body Balance30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0635BODY BALANCE (AVENA SATIVA, CHLOROPHYTUM BORIVILIANUM, NUPHAR LUTEUM, HYPOTHALAMUS SUIS, ORCHITINUM (SUIS), DAMIANA, SELENIUM METALLICUM, STAPHYSAGRIA, THUJA OCCIDENTALIS) SPRAY [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240216_d8e70220-b3ef-4595-a8c3-a77a6bd373e4.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
Body BalanceAVENA SATIVA, CHLOROPHYTUM BORIVILIANUM, NUPHAR LUTEUM, HYPOTHALAMUS SUIS, ORCHITINUM (SUIS), DAMIANA, SELENIUM METALLICUM, STAPHYSAGRIA, THUJA OCCIDENTALISEnergique, Inc.d8e70220-b3ef-4595-a8c3-a77a6bd373e42024-02-14WarningsExact identifier
ndc (product): 44911-0635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0635-14491106350130 mL in 1 BOTTLE, SPRAY (44911-0635-1) 30 ml2021-03-160000-00-00NoNoCurrent