FDA.reportPublic FDA data

Analpram HC

Product NDC
54766-799
Requested package NDC
54766-799-65
11-digit product format
547660799
Labeler code
54766
Product ID
54766-799_43146b87-2f75-b0a4-e063-6294a90a25c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone acetate and pramoxine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sebela Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-08-07
Marketing end
2026-11-30
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
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54766-79954766-799-65IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
Analpram HC

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
1294025Internal RxNorm lookup
1362211Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fecf8380-3bb5-11e5-98c5-0002a5d5c51bAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54766-799-042020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-042020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-10-14Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-042020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-042020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-01-31Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54766-799-04Analpram HC28.4 g in 1 TUBE, WITH APPLICATORCREAM28.49
54766-799-33Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM49
54766-799-36Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM49
54766-799-64Analpram HC30 in 1 CARTONCREAM309
54766-799-65Analpram HC12 in 1 CARTONCREAM129
54766-799-71Analpram HC30 in 1 CARTONCREAM309
54766-799-72Analpram HC12 in 1 CARTONCREAM129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-799-04GM - Gram54766-79922f30c36-37bb-498d-a7c0-0f1dc210b91912015-09-10
54766-799-36GM - Gram54766-799778228f1-06b8-4c66-b017-151ba72b8df412019-04-11
54766-799-64GM - Gram54766-7996e2e1a02-f671-461a-97cc-7adf30e4871012015-09-10
54766-799-65GM - Gram54766-79910c92249-b4a5-46b6-aa86-faedaad1de9412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
PRAMOXINEACTIVE MOIETY068X84E056ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
TROLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAAANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54766-799ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 7 package rows20241114_fecf8380-3bb5-11e5-98c5-0002a5d5c51b.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
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.fecf8380-3bb5-11e5-98c5-0002a5d5c51b2025-11-08Adverse reactionsExact identifier
ndc (package): 54766-799-65
ndc (product): 54766-799
ndc11 (package): 54766079965

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362211Analpram 2.5 % / 1 % Rectal CreamPSNfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1294025hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal CreamPSNfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1362211hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]SBDfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1294025hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1362211Analpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal CreamSYfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1294025hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal CreamSYfecf8380-3bb5-11e5-98c5-0002a5d5c51b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54766-799-655476607996512 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-65) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) 2015-08-072026-11-30NoNoCurrent