FDA.reportPublic FDA data

hydrocortisone acetate pramoxine HCl

Product NDC
45802-124
Requested package NDC
45802-124-64
11-digit product format
458020124
Labeler code
45802
Product ID
45802-124_1fcc432b-5d3c-491e-9375-80f4946be28d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Acetate, Pramoxine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-03-29
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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234506Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
982f0862-2be8-4a65-8b61-8f3a95ab5951Available on FDA.report

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
45802-124-16hydrocortisone acetate pramoxine HCl1 in 1 CARTONCREAM15
45802-124-16hydrocortisone acetate pramoxine HCl57 g in 1 TUBECREAM575
45802-124-64hydrocortisone acetate pramoxine HCl1 in 1 CARTONCREAM15
45802-124-64hydrocortisone acetate pramoxine HCl28.4 g in 1 TUBECREAM28.45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-124-16GM - Gram45802-124b3a349b4-5be2-4904-8907-87648be885fe12012-07-24
45802-124-64GM - Gram45802-12429c38765-cdfd-4921-838b-26c54ebddb2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74HYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5HYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
PRAMOXINEACTIVE MOIETY068X84E056HYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
TROLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAAHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-124HYDROCORTISONE ACETATE PRAMOXINE HCL (HYDROCORTISONE ACETATE, PRAMOXINE HCL) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 4 package rows20241218_982f0862-2be8-4a65-8b61-8f3a95ab5951.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd982f0862-2be8-4a65-8b61-8f3a95ab59512022-05-31Adverse reactionsExact identifier
ndc (package): 45802-124-64
ndc (product): 45802-124
ndc11 (package): 45802012464

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234506hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5b103
1234506hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN2c74c1c8-91c7-4468-9b1a-721783431196103
1234506hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5b103
1234506hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD2c74c1c8-91c7-4468-9b1a-721783431196103
1234506hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5b103
1234506hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY2c74c1c8-91c7-4468-9b1a-721783431196103
1234506hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSNc95b9248-b4cc-43ce-acd2-fe20972f87ca101
1234506hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDc95b9248-b4cc-43ce-acd2-fe20972f87ca101
1234506hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSYc95b9248-b4cc-43ce-acd2-fe20972f87ca101
1234506hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSNd59665d7-a0f4-4318-b452-171c54ed156c100
1234506hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDd59665d7-a0f4-4318-b452-171c54ed156c100
1234506hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSYd59665d7-a0f4-4318-b452-171c54ed156c100
1234506hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN982f0862-2be8-4a65-8b61-8f3a95ab59515
1234506hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD982f0862-2be8-4a65-8b61-8f3a95ab59515
1234506hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY982f0862-2be8-4a65-8b61-8f3a95ab59515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-124-64458020124641 TUBE in 1 CARTON (45802-124-64) / 28.4 g in 1 TUBE1 tube2017-03-290000-00-00NoNoCurrent