FDA.reportPublic FDA data

Care and Comfort Cream

Product NDC
44911-0639
11-digit product format
449110639
Labeler code
44911
Product ID
44911-0639_e596a666-541c-4807-a70c-4befd9813b42
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum Napellus, Arnica Montana, Bryonia (Alba), Calendula Officinalis, Chamomilla, Colocynthis, Hypericum Perforatum, Pulsatilla (Pratensis), Rhus Tox, Symphytum Officinale
Dosage form
CREAM
Route
TOPICAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-05-12
Substance
ACONITUM NAPELLUS WHOLE; ARNICA MONTANA WHOLE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; HYPERICUM PERFORATUM WHOLE; MATRICARIA CHAMOMILLA WHOLE; PHYTOLACCA AMERICANA ROOT; PULSATILLA PRATENSIS WHOLE; TOXICODENDRON PUBESCENS LEAF
Active strength
12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Care and Comfort Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE12 [hp_X]/g
ARNICA MONTANA WHOLE12 [hp_X]/g
BRYONIA ALBA ROOT12 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]/g
CITRULLUS COLOCYNTHIS FRUIT PULP12 [hp_X]/g
COMFREY ROOT12 [hp_X]/g
HYPERICUM PERFORATUM WHOLE12 [hp_X]/g
MATRICARIA CHAMOMILLA WHOLE12 [hp_X]/g
PHYTOLACCA AMERICANA ROOT12 [hp_X]/g
PULSATILLA PRATENSIS WHOLE12 [hp_X]/g
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, O80TY208ZW, T7J046YI2B, 18E7415PXQ, 23H32AOH17, M9VVZ08EKQ, XK4IUX8MNB, G0R4UBI2ZZ, 11E6VI8VEG, 8E272251DI, 6IO182RP7A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0639-12024-10-24C16284748780-11030e365-112a-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0639-12024-01-30C16284748780-11030e365-112a-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0639-1Care and Comfort Cream57 g in 1 TUBECREAM572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0639CARE AND COMFORT CREAM (ACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, HYPERICUM PERFORATUM, PULSATILLA (PRATENSIS), RHUS TOX, SYMPHYTUM OFFICINALE) CREAM [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20241027_ac8ee81f-0af4-46d4-b63f-beeb7d120f80.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0639-14491106390157 g in 1 TUBE (44911-0639-1) 57 g2022-05-120000-00-00NoNoCurrent