FDA.reportPublic FDA data

Equaline Hemorrhoidal

Product NDC
41163-188
11-digit product format
411630188
Labeler code
41163
Product ID
41163-188_570fe72a-62d7-47b3-8012-ea1de5b291f0
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
41163-188-16Equaline Hemorrhoidal57 g in 1 TUBEOINTMENT577
41163-188-16Equaline Hemorrhoidal1 in 1 CARTONOINTMENT17
41163-188-64Equaline Hemorrhoidal28 g in 1 TUBEOINTMENT287
41163-188-64Equaline Hemorrhoidal1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-188-64GM - Gram41163-188e9c2d292-4c05-43a0-80f0-672e16f954e112016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
MINERAL OILACTIVE MOIETYT5L8T28FGPEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
PETROLATUMACTIVE MOIETY4T6H12BN9UEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
CORN OILINACTIVE INGREDIENT8470G57WFMEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
LANOLININACTIVE INGREDIENT7EV65EAW6HEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
THYME OILINACTIVE INGREDIENT2UK410MY6BEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FEQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [SUPERVALU INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-188EQUALINE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [UNITED NATURAL FOODS, INC. DBA UNFI]6Current NDC, Legacy NDC, 4 package rows20241019_a6ed1987-37ad-4bfd-8cea-f03426953f5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSNa6ed1987-37ad-4bfd-8cea-f03426953f5a7
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDa6ed1987-37ad-4bfd-8cea-f03426953f5a7
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYa6ed1987-37ad-4bfd-8cea-f03426953f5a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-188-16411630188161 TUBE in 1 CARTON (41163-188-16) / 57 g in 1 TUBE1 tube2014-07-030000-00-00NoNoCurrent
41163-188-64411630188641 TUBE in 1 CARTON (41163-188-64) > 28 g in 1 TUBE1 tube2014-01-100000-00-00NoNoCurrent