FDA.reportPublic FDA data

Pramosone

Product NDC
83107-014
Requested package NDC
83107-014-01
11-digit product format
831070014
Labeler code
83107
Product ID
83107-014_4d4e288e-00d8-ed9d-e063-6394a90aab31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone acetate and pramoxine hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Legacy Pharma USA Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-03-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pramosone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE25 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234333Internal RxNorm lookup
1234338Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d4e288e-00d7-ed9d-e063-6394a90aab31Available 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
83107-014-01Pramosone28.4 g in 1 TUBEOINTMENT28.41

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
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc4d4e288e-00d7-ed9d-e063-6394a90aab312026-03-18Adverse reactionsExact identifier
ndc (package): 83107-014-01
ndc (product): 83107-014
ndc11 (package): 83107001401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234333hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical OintmentPSN4d4e288e-00d7-ed9d-e063-6394a90aab311
1234338Pramosone 2.5 % / 1 % Topical OintmentPSN4d4e288e-00d7-ed9d-e063-6394a90aab311
1234338hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]SBD4d4e288e-00d7-ed9d-e063-6394a90aab311
1234333hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD4d4e288e-00d7-ed9d-e063-6394a90aab311
1234333hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical OintmentSY4d4e288e-00d7-ed9d-e063-6394a90aab311
1234338Pramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical OintmentSY4d4e288e-00d7-ed9d-e063-6394a90aab311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83107-014-018310700140128.4 g in 1 TUBE (83107-014-01) 28.4 g2026-03-18NoNoCurrent