FDA.reportPublic FDA data

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE

Product NDC
75834-197
11-digit product format
758340197
Labeler code
75834
Product ID
75834-197_53ac723b-1f67-47e5-b560-6589342a27d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAMOXINE HYDROCHLORIDE and HYDROCORTISONE ACETATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Nivagen Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-04-29
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
25; 10 mg/g; mg/g
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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE25 mg/g
HYDROCORTISONE ACETATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1294025Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc7f17e4-76f8-4cd4-a7e3-43032b386b74Available 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
75834-197-01HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE28.5 g in 1 TUBE, WITH APPLICATORCREAM28.53
75834-197-01HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-197-01GM - Gram75834-197b7c41d18-1d74-4648-aaab-d2fc87ab8d6712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-197HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE (PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE) CREAM [NIVAGEN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20230113_dc7f17e4-76f8-4cd4-a7e3-43032b386b74.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 HYDROCHLORIDEPRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATENivagen Pharmaceuticals Inc.dc7f17e4-76f8-4cd4-a7e3-43032b386b742023-01-12Adverse reactionsExact identifier
ndc (product): 75834-197

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294025hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal CreamPSNdc7f17e4-76f8-4cd4-a7e3-43032b386b743
1294025hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDdc7f17e4-76f8-4cd4-a7e3-43032b386b743
1294025hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal CreamSYdc7f17e4-76f8-4cd4-a7e3-43032b386b743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-197-01758340197011 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01) / 28.5 g in 1 TUBE, WITH APPLICATOR2019-04-290000-00-00NoNoCurrent