FDA.reportPublic FDA data

H Acne Formula

Product NDC
57520-1111
11-digit product format
575201111
Labeler code
57520
Product ID
57520-1111_70548b27-1925-44c6-8999-f5f47984a6bd
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula officinalis, Nux vomica, Silicea,
Dosage form
OIL
Route
TOPICAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-03-13
Marketing end
2026-06-24
Substance
CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED
Active strength
12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
H Acne Formula

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii18E7415PXQ, ETJ7Z6XBU4, 269XH13919

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-1111-12020-01-31C16284748780-19d75b9d0-efad-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57520-1111-1H Acne Formula33 mL in 1 BOTTLE, DROPPEROIL332

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQH ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4H ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919H ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQH ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4H ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919H ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MH ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
CARROT SEED OILINACTIVE INGREDIENT595AO13F11H ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
GERANIUM OIL, ALGERIAN TYPEINACTIVE INGREDIENT5Q1I94P4WGH ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
HELICHRYSUM ITALICUM FLOWER OILINACTIVE INGREDIENTO97ZV7726KH ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8H ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
PALMAROSA OILINACTIVE INGREDIENT0J3G3O53STH ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GH ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57520-1111H ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA,) OIL [APOTHECA COMPANY]1Current NDC, Legacy NDC, 1 package rows20120314_cb16364f-446f-45ec-9232-4b7b0b98a88d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-1111-15752011110133 mL in 1 BOTTLE, DROPPER (57520-1111-1) 33 ml2012-03-132026-06-24NoNoHistorical