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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Avoid contact with eyes. Do not use if you have a vaginal discharge. Consult a doctor When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days beeding occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

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 tube2022-12-09NoNoCurrent