FDA.reportPublic FDA data

Bite Calm

Product NDC
76472-7001
Requested package NDC
76472-7001-2
11-digit product format
764727001
Labeler code
76472
Product ID
76472-7001_594f6108-d817-9551-e063-6294a90a5f84
Type
HUMAN OTC DRUG
Nonproprietary name
Apis mellifica 9C, Histaminum hydrochloricum 5C, Lappa Major 3C, Urtica urens 5C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
URTICA URENS; ARCTIUM LAPPA ROOT; APIS MELLIFERA; HISTAMINE DIHYDROCHLORIDE
Active strength
.1; .1; .1; .1 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
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
Bite Calm
Brand name suffix
Stings and Itching
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URTICA URENS.1 mg/100mL
ARCTIUM LAPPA ROOT.1 mg/100mL
APIS MELLIFERA.1 mg/100mL
HISTAMINE DIHYDROCHLORIDE.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IHN2NQ5OF9Internal UNII lookup
597E9BI3Z3Internal UNII lookup
7S82P3R43ZInternal UNII lookup
3POA0Q644UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5486f4ff-f036-8596-e063-6394a90a0b33Available 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
Bite Calm Stings and ItchingAPIS MELLIFICA 9C, HISTAMINUM HYDROCHLORICUM 5C, LAPPA MAJOR 3C, URTICA URENS 5CSEVENE USA5486f4ff-f036-8596-e063-6394a90a0b332026-08-18WarningsExact identifier
ndc (package): 76472-7001-2
ndc (product): 76472-7001
ndc11 (package): 76472700102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7001-2764727001021 BOTTLE, SPRAY in 1 BOX (76472-7001-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7001-1) 2026-08-19NoNoCurrent