FDA.reportPublic FDA data

BABY ACNE

Product NDC
52810-214
Requested package NDC
52810-214-11
11-digit product format
528100214
Labeler code
52810
Product ID
52810-214_cdb74469-6755-5270-e053-2a95a90a7fdf
Type
HUMAN OTC DRUG
Nonproprietary name
CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS
Dosage form
SALVE
Route
TOPICAL
Labeler
PUREMEDY
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-10-18
Marketing end
0000-00-00
Substance
CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAF
Active strength
1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage52810-21452810-214-11IInactivated by FDA2026-10-05

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52810-21452810-214-11IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52810-21452810-214-11IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52810-21452810-214-11IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52810-214-112025-07-29C16284748780-19855e2a2-4f0b-60a7-e053-dbdaa90a05bdBABY ACNE (52810-214)
52810-214-112020-04-16C16284748780-19855e2a2-4f0b-60a7-e053-dbdaa90a05bdBABY ACNE (52810-214)
52810-214-112019-11-27C16284748780-19855e2a2-4f0b-60a7-e053-dbdaa90a05bdBABY ACNE (52810-214)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-214-11BABY ACNE30 mL in 1 JARSALVE306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YDBABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094TBABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
THUJA OCCIDENTALIS LEAFACTIVE INGREDIENT0T0DQN8786BABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YDBABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094TBABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
THUJA OCCIDENTALIS LEAFACTIVE MOIETY0T0DQN8786BABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
CANADA BALSAMINACTIVE INGREDIENTK304VI98I3BABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRBABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EBABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-214BABY ACNE (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS) SALVE [PUREMEDY]6Legacy NDC, 1 package rows20240112_09b4e4a7-f69a-4bfd-8ecc-eac4543f7ab1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52810-214-115281002141130 mL in 1 JAR (52810-214-11) 30 ml2012-10-180000-00-00NoNoCurrent