H-Rosacea Formula

Product NDC
61077-121
11-digit product format
610770121
Labeler code
61077
Product ID
61077-121_34491b5f-1c37-4c7d-9093-0ee74062fbc2
Type
HUMAN OTC DRUG
Nonproprietary name
belladonna, nux vomica
Dosage form
OIL
Route
TOPICAL
Labeler
Healing Natural Oils LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-11-06
Substance
ATROPA BELLADONNA; STRYCHNOS NUX-VOMICA SEED
Active strength
6; 12 [hp_C]/11mL; [hp_C]/11mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
H-Rosacea Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPA BELLADONNA6 [hp_C]/11mL
STRYCHNOS NUX-VOMICA SEED12 [hp_C]/11mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WQZ3G9PF0HInternal UNII lookup
269XH13919Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f00b0028-4340-4219-8890-f66590a2a04dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-121-11H-Rosacea Formula11 mL in 1 BOTTLE, DROPPEROIL112
61077-121-33H-Rosacea Formula33 mL in 1 BOTTLE, DROPPEROIL332

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919H-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919H-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
CARROT SEED OILINACTIVE INGREDIENT595AO13F11H-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
CUPRESSUS SEMPERVIRENS LEAFY TWIGINACTIVE INGREDIENT7HB6L93P3UH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
EUROPEAN HAZELNUT OILINACTIVE INGREDIENT8RQ2839AVGH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
HELICHRYSUM ITALICUM FLOWERINACTIVE INGREDIENTP62Y550X24H-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
LAVANDULA ANGUSTIFOLIA FLOWERING TOPINACTIVE INGREDIENT9YT4B71U8PH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162KH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1
PELARGONIUM GRAVEOLENS WHOLEINACTIVE INGREDIENT0E553RP62FH-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-121H-ROSACEA FORMULA (BELLADONNA, NUX VOMICA) OIL [HEALING NATURAL OILS LLC]2Current NDC, Legacy NDC, 2 package rows20171228_f00b0028-4340-4219-8890-f66590a2a04d.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
H-Rosacea FormulaBELLADONNA, NUX VOMICAHealing Natural Oils LLCf00b0028-4340-4219-8890-f66590a2a04d2017-12-27WarningsExact identifier
ndc (product): 61077-121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61077-121-116107701211111 mL in 1 BOTTLE, DROPPER (61077-121-11) 11 ml2013-11-060000-00-00NoNoCurrent
61077-121-336107701213333 mL in 1 BOTTLE, DROPPER (61077-121-33) 33 ml2013-11-060000-00-00NoNoCurrent