FDA.reportPublic FDA data

Natureplex Hydrocortisone

Product NDC
67234-010
11-digit product format
672340010
Labeler code
67234
Product ID
67234-010_c04d26f2-8870-4d41-91a9-519c349b517a
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Natureplex, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-22
Substance
HYDROCORTISONE
Active strength
.01 g/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Natureplex Hydrocortisone
Brand name suffix
Hydro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE.01 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui106258

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-010-01Natureplex HydrocortisoneHydro28 g in 1 TUBECREAM2816
67234-010-02Natureplex HydrocortisoneHydro42.5 g in 1 TUBECREAM42.516
67234-010-02Natureplex HydrocortisoneHydro1 in 1 CARTONCREAM116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67234-010-01GM - Gram67234-010c4e34dac-eadb-4f14-8d58-68c39ddb36bd12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
HydrocortisoneACTIVE MOIETYWI4X0X7BPJNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
alcoholINACTIVE INGREDIENT3K9958V90MNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
carbomer homopolymer type CINACTIVE INGREDIENT4Q93RCW27ENATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
cetyl alcoholINACTIVE INGREDIENT936JST6JCNNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
DMDM HydantoinINACTIVE INGREDIENTBYR0546TOWNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
edetate trisodiumINACTIVE INGREDIENT420IP921MBNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
mineral oilINACTIVE INGREDIENTT5L8T28FGPNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
stearic acidINACTIVE INGREDIENT4ELV7Z65APNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
trolamineINACTIVE INGREDIENT9O3K93S3TKNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12
waterINACTIVE INGREDIENT059QF0KO0RNATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-010NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]14Current NDC, Legacy NDC, 3 package rows20250101_2fc6a148-34bb-4289-8588-32c1bb011b98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN2fc6a148-34bb-4289-8588-32c1bb011b9816
106258hydrocortisone 10 MG/ML Topical CreamSCD2fc6a148-34bb-4289-8588-32c1bb011b9816
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY2fc6a148-34bb-4289-8588-32c1bb011b9816
106258hydrocortisone 1 % Topical CreamSY2fc6a148-34bb-4289-8588-32c1bb011b9816
106258hydrocortisone 1 GM per 100 GM Topical CreamSY2fc6a148-34bb-4289-8588-32c1bb011b9816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-010-016723400100128 g in 1 TUBE (67234-010-01) 28 g2008-01-220000-00-00NoNoCurrent
67234-010-02672340010021 TUBE in 1 CARTON (67234-010-02) / 42.5 g in 1 TUBE1 tube2022-12-09NoNoHistorical