H Acne Formula

Product NDC
57520-1111
Requested package NDC
57520-1111-1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57520-111157520-1111-1DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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