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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-18841163-188-64DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1372298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6ed1987-37ad-4bfd-8cea-f03426953f5aAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Numb520SprayLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.350f0e25-fbdc-c0c0-e063-6294a90a50a02026-08-20WarningsExact identifier
application number: M015
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsExact identifier
application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)LIDOCAINE 5%EveryMarket Inc52379055-d017-4d98-e063-6294a90a196c2026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc52369a41-820d-cd7a-e063-6394a90ac6d12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc51d370b4-1c34-d203-e063-6394a90a80b12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD 5% Lidocaine creamLIDOCAINE 5%EveryMarket Inc507d0c2c-9517-40f8-e063-6394a90a19962026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)LIDOCAINE CREAM ANORECTALEveryMarket Inc483d81a3-7493-3391-e063-6394a90a2e3d2026-08-12WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
application number: M015
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
application number: M015
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
application number: M015
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL NumbingLIDOCAINEPutian Licheng District Zhijiancheng Trading Co., Ltd.4a7be9eb-5e57-90e8-e063-6394a90aad9e2026-08-08WarningsExact identifier
application number: M015
THE SOLU TIONLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDESCALP TECH INC58793581-8826-9a74-e063-6294a90a24652026-08-06WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsExact identifier
application number: M015
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015

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