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; LANOLIN; LIDOCAINE; ZINC OXIDE
Active strength
37.5; 12.5; 4; 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

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
LANOLIN12.5 g/100g
LIDOCAINE4 g/100g
ZINC OXIDE5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 7EV65EAW6H, 98PI200987, SOI2LOH54Z
Rxcui2586855

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

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