FDA.reportPublic FDA data

Smooth Breath

Product NDC
76472-7005
Requested package NDC
76472-7005-2
11-digit product format
764727005
Labeler code
76472
Product ID
76472-7005_594f58b9-1210-49ee-e063-6394a90a5f97
Type
HUMAN OTC DRUG
Nonproprietary name
Bryonia 5C, Drosera 5C, Mentha piperita 3C, Spongia tosta 5C, Verbascum thapsus 3C, Viola odorata 3C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
VERBASCUM THAPSUS WHOLE; DROSERA ROTUNDIFOLIA WHOLE; BRYONIA CRETICA SUBSP. DIOICA ROOT; MENTHA PIPERITA; SPONGIA OFFICINALIS WHOLE; VIOLA ODORATA WHOLE
Active strength
.1; .1; .1; .1; .1; .1 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
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
Smooth Breath
Brand name suffix
Spasmodic cough
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERBASCUM THAPSUS WHOLE.1 mg/100mL
DROSERA ROTUNDIFOLIA WHOLE.1 mg/100mL
BRYONIA CRETICA SUBSP. DIOICA ROOT.1 mg/100mL
MENTHA PIPERITA.1 mg/100mL
SPONGIA OFFICINALIS WHOLE.1 mg/100mL
VIOLA ODORATA WHOLE.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C9TD27U172Internal UNII lookup
QR44N9XPJQInternal UNII lookup
53UB5FH7CXInternal UNII lookup
79M2M2UDA9Internal UNII lookup
755U7L3M7ZInternal UNII lookup
AET12U8B74Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54eb17ad-c834-db86-e063-6294a90a5897Available 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smooth Breath Spasmodic coughBRYONIA 5C, DROSERA 5C, MENTHA PIPERITA 3C, SPONGIA TOSTA 5C, VERBASCUM THAPSUS 3C, VIOLA ODORATA 3CSEVENE USA54eb17ad-c834-db86-e063-6294a90a58972026-08-18WarningsExact identifier
ndc (package): 76472-7005-2
ndc (product): 76472-7005
ndc11 (package): 76472700502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7005-2764727005021 BOTTLE, SPRAY in 1 BOX (76472-7005-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7005-1) 2026-08-19NoNoCurrent