FDA.reportPublic FDA data

Hemorrhoidal Cream

Product NDC
70000-0425
11-digit product format
700000425
Labeler code
70000
Product ID
70000-0425_0884bc8d-70d0-80db-e063-6294a90a6582
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, White Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-30
Substance
GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
4.032; 4.2; .07; .28 g/28g; g/28g; g/28g; g/28g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hemorrhoidal Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN4.032 g/28g
PETROLATUM4.2 g/28g
PHENYLEPHRINE HYDROCHLORIDE.07 g/28g
PRAMOXINE HYDROCHLORIDE.28 g/28g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 4T6H12BN9U, 04JA59TNSJ, 88AYB867L5
Rxcui1293649

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0425-12023-02-14C16284748780-1f386c64a-1597-0266-e053-dadaa90a7c1aMAX STRENTH PAIN RELIEF HEMORRHOIDAL CREAM
70000-0425-12023-01-30C16284748780-1f386c64a-1597-0266-e053-dadaa90a7c1aMAX STRENTH PAIN RELIEF HEMORRHOIDAL CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0425-1Hemorrhoidal Cream1 in 1 BOXCREAM14
70000-0425-1Hemorrhoidal Cream28 g in 1 TUBECREAM284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0425-1GM - Gram70000-0425d31547e8-ac4a-44d2-8185-27838bf5b24112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0425HEMORRHOIDAL CREAM (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM) CREAM [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 2 package rows20231025_85a51d5c-679e-1959-e053-2a91aa0a76d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN85a51d5c-679e-1959-e053-2a91aa0a76d54
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD85a51d5c-679e-1959-e053-2a91aa0a76d54
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY85a51d5c-679e-1959-e053-2a91aa0a76d54
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSNf4c215c2-3dd1-a6a8-e053-2995a90a4a091
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDf4c215c2-3dd1-a6a8-e053-2995a90a4a091
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSYf4c215c2-3dd1-a6a8-e053-2995a90a4a091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0425-1700000425011 TUBE in 1 BOX (70000-0425-1) / 28 g in 1 TUBE1 tube2020-12-300000-00-00NoNoCurrent