FDA.reportPublic FDA data

hydrocortisone acetate pramoxine HCl

Product NDC
52817-817
11-digit product format
528170817
Labeler code
52817
Product ID
52817-817_2a458b2c-3556-7f1e-e063-6294a90a074c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Acetate, Pramoxine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
TRUPHARMA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-19
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
2.5; 1 g/100g; 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

Additional Listing Data#

Finished product
Yes
Brand name base
hydrocortisone acetate pramoxine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE2.5 g/100g
PRAMOXINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, 88AYB867L5
Rxcui1234506

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
52817-817-01hydrocortisone acetate pramoxine HCl1 in 1 CARTONCREAM14
52817-817-01hydrocortisone acetate pramoxine HCl28.4 g in 1 TUBECREAM28.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-817HYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [TRUPHARMA, LLC]4Current NDC, Legacy NDC, 2 package rows20241228_f531fa34-5711-42d0-82c4-3b9943cdcca9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234506hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSNf531fa34-5711-42d0-82c4-3b9943cdcca94
1234506hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDf531fa34-5711-42d0-82c4-3b9943cdcca94
1234506hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSYf531fa34-5711-42d0-82c4-3b9943cdcca94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-817-01528170817011 TUBE in 1 CARTON (52817-817-01) / 28.4 g in 1 TUBE1 tube2020-11-190000-00-00NoNoCurrent