FDA.reportPublic FDA data

Doctor Butler Hemorrhoid and Fissure

Product NDC
70942-517
11-digit product format
709420517
Labeler code
70942
Product ID
70942-517_3a9b3c55-04fb-8c74-e063-6294a90a0de8
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin 37.5%, Lanolin 12.5%, Lidocaine 4%, Zinc Oxide 5%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Beyond Health, PA
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-20
Substance
GLYCERIN; LIDOCAINE; LANOLIN; ZINC OXIDE
Active strength
37.5; 4; 12.5; 5 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Doctor Butler Hemorrhoid and Fissure
Brand name suffix
Advanced Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN37.5 g/100g
LIDOCAINE4 g/100g
LANOLIN12.5 g/100g
ZINC OXIDE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
98PI200987Internal UNII lookup
7EV65EAW6HInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2586855Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2a769e2-afd0-aed2-e053-2995a90ad429Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-517-00Doctor Butler Hemorrhoid and FissureAdvanced Formula42.5 g in 1 TUBEOINTMENT42.55
70942-517-01Doctor Butler Hemorrhoid and FissureAdvanced Formula1 in 1 CARTONOINTMENT15
70942-517-07Doctor Butler Hemorrhoid and FissureAdvanced Formula21.3 g in 1 TUBEOINTMENT21.35
70942-517-75Doctor Butler Hemorrhoid and FissureAdvanced Formula1 in 1 CARTONOINTMENT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70942-517-75GM - Gram70942-51774d85261-c665-4253-a65e-66ae1f7b304b12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70942-517DOCTOR BUTLER HEMORRHOID AND FISSURE ADVANCED FORMULA (GLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%) OINTMENT [BEYOND HEALTH, PA]3Current NDC, Legacy NDC, 4 package rows20241217_d2a769e2-afd0-aed2-e053-2995a90ad429.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 6 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC8d9961f0-1ecf-d7fb-b6b4-856d636d68e12026-03-17WarningsExact identifier
application number: M015
Crane Safety BurnLIDOCAINECrane Safety LLC96d81566-6321-731e-e053-2995a90ad07d2026-03-16WarningsExact identifier
application number: M015
Signature Lidocaine Pain Relief Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4c56b3b3-33b3-a50e-e063-6394a90a955f2026-03-06WarningsExact identifier
application number: M015
WowDay Medicated Hemorrhoidal Flushable WipesMEDICATED HEMORRHOIDAL FLUSHABLE WIPESWowDay LLC4c603b27-4835-bc40-e063-6394a90a8ea22026-03-06WarningsExact identifier
application number: M015
Numb Fast HemorrhoidalLIDOCAINEOasis Plus LLCa00ffed7-8034-4cc0-87c4-3c793c1bcd6e2026-03-03WarningsExact identifier
application number: M015
Curist Lidocaine ReliefLIDOCAINE 5%Little Pharma, Inc.f562b57d-6592-93fa-e053-2995a90ae3e02026-03-02WarningsExact identifier
application number: M015
Therapain PlusMENTHOL ROLL-ONEpic Laboratories, LLC0249cfdf-b7c4-f27d-e063-6294a90aaa262026-03-02WarningsExact identifier
application number: M015
Liposomal Hemorrhoid MasterLIDOCAINE , PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.a1e15d2a-44b6-4d9c-89c2-0ff12285724e2026-03-02WarningsExact identifier
application number: M015
Equate Hemorrhoid ReliefLIDOCAINEWalmart Inc.48646860-ed5d-62a0-e063-6394a90abb232026-03-01WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELThe Kroger Co.bbf2efd7-f181-403b-ac5f-695f7ba158752026-02-27Warnings, Adverse reactionsExact identifier
application number: M015
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
application number: M015
Megababe Fun Gal Stuff AntifungalCLOTRIMAZOLEMegababe LLCc599d27b-fdb0-465f-9e43-13d32c520a922026-02-25WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELBetter Living Brands, LLC0355edab-b6f7-4e59-bce1-cf6a8897b9892026-02-24Warnings, Adverse reactionsExact identifier
application number: M015
Zinc Oxide and MentholZINC OXIDE, MENTHOLAkron Formulations India Private Limited4b84556c-521f-eebd-e063-6394a90a8e1e2026-02-23WarningsExact identifier
application number: M015
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.41d9d0b4-33e7-7e05-e063-6394a90a10112026-02-17WarningsExact identifier
application number: M015
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
application number: M015
Gniby - LIDOCAINE ANORECTAL HEMORRHOIDALNUMBINGPutian Licheng District Zhijiancheng Trading Co., Ltd.4a5f59f1-c11a-e2eb-e063-6394a90a3e272026-02-10WarningsExact identifier
application number: M015
Numb MasterLIDOCAINEClinical Resolution Laboratory, Inc.0921c824-a8a9-4707-a480-c750192983f52026-02-09WarningsExact identifier
application number: M015
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2586855glycerin 37.5 % / lanolin 12.5 % / lidocaine 4 % / zinc oxide 5 % Topical OintmentPSNd2a769e2-afd0-aed2-e053-2995a90ad4295
2586855glycerin 0.375 MG/MG / lanolin 0.125 MG/MG / lidocaine 0.04 MG/MG / zinc oxide 0.05 MG/MG Topical OintmentSCDd2a769e2-afd0-aed2-e053-2995a90ad4295
2586855glycerin 0.375 MG/MG / lanolin 0.125 MG/MG / lidocaine 0.04 MG/MG / ZNO 0.05 MG/MG Topical OintmentSYd2a769e2-afd0-aed2-e053-2995a90ad4295
2586855glycerin 37.5 % / lanolin 12.5 % / lidocaine 4 % / zinc oxide 5 % Topical or Intrarectal OintmentSYd2a769e2-afd0-aed2-e053-2995a90ad4295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70942-517-007094205170042.5 g in 1 TUBE42.5 gHistorical
70942-517-01709420517011 TUBE in 1 CARTON (70942-517-01) / 42.5 g in 1 TUBE (70942-517-00) 1 tube2021-09-200000-00-00NoNoCurrent
70942-517-077094205170721.3 g in 1 TUBE21.3 gHistorical
70942-517-75709420517751 TUBE in 1 CARTON (70942-517-75) / 21.3 g in 1 TUBE (70942-517-07) 1 tube2025-07-22NoNoCurrent