H-Acne Formula

Product NDC
61077-020
11-digit product format
610770020
Labeler code
61077
Product ID
61077-020_8d32a590-f3d8-4237-b0dd-6a94389dc1d2
Type
HUMAN OTC DRUG
Nonproprietary name
calendula officinalis, nux vomica, silicea
Dosage form
OIL
Route
TOPICAL
Labeler
Healing Natural Oils LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-11-06
Substance
CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED
Active strength
12; 12; 12 [hp_C]/11mL; [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

Additional Listing Data#

Finished product
Yes
Brand name base
H-Acne Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWERING TOP12 [hp_C]/11mL
SILICON DIOXIDE12 [hp_C]/11mL
STRYCHNOS NUX-VOMICA SEED12 [hp_C]/11mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii18E7415PXQ, ETJ7Z6XBU4, 269XH13919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-020-11H-Acne Formula11 mL in 1 BOTTLE, DROPPEROIL114
61077-020-33H-Acne Formula33 mL in 1 BOTTLE, DROPPEROIL334

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQH-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQH-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
CYMBOPOGON MARTINI TOPINACTIVE INGREDIENT7K1N3UZ6DUH-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
DAUCUS CAROTA SUBSP. SATIVUS SEEDINACTIVE INGREDIENT9M6AAX381UH-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
HELICHRYSUM ITALICUM FLOWERINACTIVE INGREDIENTP62Y550X24H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4MH-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162KH-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3
PELARGONIUM GRAVEOLENS WHOLEINACTIVE INGREDIENT0E553RP62FH-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-020H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]4Current NDC, Legacy NDC, 2 package rows20171227_fd9598ac-8f69-4fba-99c1-4234c8afcafd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61077-020-116107700201111 mL in 1 BOTTLE, DROPPER (61077-020-11) 11 ml2013-11-060000-00-00NoNoCurrent
61077-020-336107700203333 mL in 1 BOTTLE, DROPPER (61077-020-33) 33 ml2013-11-060000-00-00NoNoCurrent