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; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE
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

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-Acne Formula
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18E7415PXQInternal UNII lookup
269XH13919Internal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd9598ac-8f69-4fba-99c1-4234c8afcafdAvailable on FDA.report

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

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-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
ndc (product): 61077-020

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