FDA.reportPublic FDA data

Psoriasis Skin Cream

Product NDC
53448-0001
11-digit product format
534480001
Labeler code
53448
Product ID
53448-0001_f32f5eb5-4561-49c3-935b-a6f278efa793
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis Aquifolium, Calendula Officinalis, Hydrocotyle Asiatica, Thuja Occidentalis, Borax, Natrum Muriaticum
Dosage form
CREAM
Route
TOPICAL
Labeler
Natural Products Ctr
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-04-25
Marketing end
2026-06-30
Substance
AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWERING TOP; CENTELLA ASIATICA; MAHONIA AQUIFOLIUM ROOT BARK; SODIUM BORATE; SODIUM CHLORIDE; TETRAARSENIC TETRASULFIDE; THUJA OCCIDENTALIS LEAF; TURMERIC
Active strength
3; 3; 3; 1; 8; 8; 12; 3; 12 [hp_C]/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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Psoriasis Skin Cream

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZADIRACHTA INDICA BARK3 [hp_C]/g
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/g
CENTELLA ASIATICA3 [hp_X]/g
MAHONIA AQUIFOLIUM ROOT BARK1 [hp_X]/g
SODIUM BORATE8 [hp_X]/g
SODIUM CHLORIDE8 [hp_X]/g
TETRAARSENIC TETRASULFIDE12 [hp_X]/g
THUJA OCCIDENTALIS LEAF3 [hp_X]/g
TURMERIC12 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG580B439YI, 18E7415PXQ, 7M867G6T1U, VZJ9F3C3SB, 91MBZ8H3QO, 451W47IQ8X, ZIK02R2PSD, 0T0DQN8786, 856YO1Z64F

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53448-0001-12020-01-31C16284748780-19d75b9d1-181e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53448-0001-1Psoriasis Skin Cream113.4 g in 1 JARCREAM113.42

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZADIRACHTA INDICA BARKACTIVE INGREDIENTG580B439YIPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CENTELLA ASIATICAACTIVE INGREDIENT7M867G6T1UPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
MAHONIA AQUIFOLIUM ROOT BARKACTIVE INGREDIENTVZJ9F3C3SBPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QOPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
TETRAARSENIC TETRASULFIDEACTIVE INGREDIENTZIK02R2PSDPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
THUJA OCCIDENTALIS LEAFACTIVE INGREDIENT0T0DQN8786PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
TURMERICACTIVE INGREDIENT856YO1Z64FPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
AZADIRACHTA INDICA BARKACTIVE MOIETYG580B439YIPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
BORATE IONACTIVE MOIETY44OAE30D22PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CENTELLA ASIATICAACTIVE MOIETY7M867G6T1UPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
MAHONIA AQUIFOLIUM ROOT BARKACTIVE MOIETYVZJ9F3C3SBPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
TETRAARSENIC TETRASULFIDEACTIVE MOIETYZIK02R2PSDPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
THUJA OCCIDENTALIS LEAFACTIVE MOIETY0T0DQN8786PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
TURMERICACTIVE MOIETY856YO1Z64FPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
SANDALWOOD OILINACTIVE INGREDIENTX7X01WMQ5FPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1
WATERINACTIVE INGREDIENT059QF0KO0RPSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53448-0001PSORIASIS SKIN CREAM (BERBERIS AQUIFOLIUM, CALENDULA OFFICINALIS, HYDROCOTYLE ASIATICA, THUJA OCCIDENTALIS, BORAX, NATRUM MURIATICUM) CREAM [NATURAL PRODUCTS CTR]1Current NDC, Legacy NDC, 1 package rows20130502_51cf61a6-6531-4daf-ad1e-d04119e4ea83.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53448-0001-153448000101113.4 g in 1 JAR (53448-0001-1) 113.4 g2013-04-252026-06-30NoNoHistorical