FDA.reportPublic FDA data

Signature Care Hemorrhoidal Cream (with applicator)

Product NDC
21130-981
11-digit product format
211300981
Labeler code
21130
Product ID
21130-981_41ecac83-195d-7b49-e063-6394a90a1b27
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
BETTER LIVING BRANDS, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-04
Substance
GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g
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
Signature Care Hemorrhoidal Cream (with applicator)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN144 mg/g
PETROLATUM150 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-981-02Signature Care Hemorrhoidal Cream (with applicator)1 in 1 CARTONCREAM14
21130-981-02Signature Care Hemorrhoidal Cream (with applicator)57 g in 1 TUBE, WITH APPLICATORCREAM574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-981SIGNATURE CARE HEMORRHOIDAL CREAM (WITH APPLICATOR) (PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUM) CREAM [BETTER LIVING BRANDS, LLC]3Current NDC, Legacy NDC, 2 package rows20241222_b026a386-5e38-52ed-e053-2a95a90a6b0e.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 CreamPSNb026a386-5e38-52ed-e053-2a95a90a6b0e4
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDb026a386-5e38-52ed-e053-2a95a90a6b0e4
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSYb026a386-5e38-52ed-e053-2a95a90a6b0e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-981-02211300981021 TUBE, WITH APPLICATOR in 1 CARTON (21130-981-02) / 57 g in 1 TUBE, WITH APPLICATOR2021-01-040000-00-00NoNoCurrent