Cortizone 10 Water Resistant

Product NDC
41167-0344
11-digit product format
411670344
Labeler code
41167
Product ID
41167-0344_7fa83555-178b-476a-a1a6-ee1e2246b681
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings For external use only Do not use ■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor. When using this product ■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly 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 occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor ■ rectal bleeding occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Cortizone 10 Water Resistant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui203105, 206314

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
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
41167-0344-0Cortizone 10 Water Resistant28 g in 1 TUBEOINTMENT284
41167-0344-0Cortizone 10 Water Resistant1 in 1 CARTONOINTMENT14
41167-0344-5Cortizone 10 Water Resistant56 g in 1 TUBEOINTMENT564
41167-0344-5Cortizone 10 Water Resistant1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0344CORTIZONE 10 WATER RESISTANT (HYDROCORTISONE) OINTMENT [CHATTEM, INC.]3Current NDC, Legacy NDC, 4 package rows20231207_118e55e7-241f-44c4-959e-09bf6221bd77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206314Cortizone-10 1 % Topical OintmentPSN118e55e7-241f-44c4-959e-09bf6221bd774
203105hydrocortisone 1 % Topical OintmentPSN118e55e7-241f-44c4-959e-09bf6221bd774
206314hydrocortisone 0.01 MG/MG Topical Ointment [Cortizone]SBD118e55e7-241f-44c4-959e-09bf6221bd774
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD118e55e7-241f-44c4-959e-09bf6221bd774
206314Cortizone 0.01 MG/MG Topical OintmentSY118e55e7-241f-44c4-959e-09bf6221bd774
206314Cortizone 1 % Topical OintmentSY118e55e7-241f-44c4-959e-09bf6221bd774
203105hydrocortisone 1 % Topical OintmentSY118e55e7-241f-44c4-959e-09bf6221bd774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0344-0411670344001 TUBE in 1 CARTON (41167-0344-0) / 28 g in 1 TUBE1 tube2023-01-010000-00-00NoNoCurrent
41167-0344-5411670344051 TUBE in 1 CARTON (41167-0344-5) / 56 g in 1 TUBE1 tube2023-01-010000-00-00NoNoCurrent