FDA.reportPublic FDA data

Equate Hemorrhoidal

Product NDC
49035-188
11-digit product format
490350188
Labeler code
49035
Product ID
49035-188_3f3c32cd-468d-42aa-93f9-a7c7815b8b9b
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL
Labeler
Wal-Mart Stores Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-02
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14; 74.9; .25 g/100g; g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
Equate Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL14 g/100g
PETROLATUM74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-188-16Equate Hemorrhoidal57 g in 1 TUBEOINTMENT574
49035-188-16Equate Hemorrhoidal1 in 1 CARTONOINTMENT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
MINERAL OILACTIVE MOIETYT5L8T28FGPEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
PETROLATUMACTIVE MOIETY4T6H12BN9UEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
CORN OILINACTIVE INGREDIENT8470G57WFMEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
THYME OILINACTIVE INGREDIENT2UK410MY6BEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
WATERINACTIVE INGREDIENT059QF0KO0REQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FEQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-188EQUATE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [WAL-MART STORES INC]4Current NDC, Legacy NDC, 2 package rows20241019_81ecb091-38da-4b3e-a0a1-b4986b97ee09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN81ecb091-38da-4b3e-a0a1-b4986b97ee094
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD81ecb091-38da-4b3e-a0a1-b4986b97ee094
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY81ecb091-38da-4b3e-a0a1-b4986b97ee094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-188-16490350188161 TUBE in 1 CARTON (49035-188-16) / 57 g in 1 TUBE1 tube2014-01-020000-00-00NoNoCurrent