FDA.reportPublic FDA data

Signature Care Hemorrhoidal

Product NDC
21130-789
11-digit product format
211300789
Labeler code
21130
Product ID
21130-789_4a197084-aa10-02ef-e063-6394a90a1e46
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil, Petrolatum, and Phenylephrine HCI
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Better Living Brands, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-20
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
140; 749; 2.5 mg/g; mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Signature Care Hemorrhoidal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL140 mg/g
PETROLATUM749 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U, 04JA59TNSJ
Rxcui1372298

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
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-789-142025-01-30C16284748780-12cef2736-b62b-d83d-e063-dadaa90ab31fSignature Care Hemorrhoidal Ointment 1 oz (with applicator) 78982 ZDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-789-14Signature Care Hemorrhoidal1 in 1 CARTONOINTMENT17
21130-789-14Signature Care Hemorrhoidal28 g in 1 TUBEOINTMENT287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-789SIGNATURE CARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCI) OINTMENT [BETTER LIVING BRANDS, LLC]6Current NDC, Legacy NDC, 2 package rows20221217_3c8b43f3-6e1e-499e-ba71-ffdf836f6743.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN3c8b43f3-6e1e-499e-ba71-ffdf836f67437
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD3c8b43f3-6e1e-499e-ba71-ffdf836f67437
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY3c8b43f3-6e1e-499e-ba71-ffdf836f67437

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-789-14211300789141 TUBE in 1 CARTON (21130-789-14) / 28 g in 1 TUBE1 tube2016-01-210000-00-00NoNoCurrent