FDA.reportPublic FDA data

Doctor Butlers Hemorrhoid and Fissure

Product NDC
70942-121
11-digit product format
709420121
Labeler code
70942
Product ID
70942-121_40079b30-9401-2783-e063-6394a90acd0b
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 5%
Dosage form
CREAM
Route
TOPICAL
Labeler
Beyond Health, P.A.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
Substance
LIDOCAINE
Active strength
5 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage70942-12170942-121-11DDiscontinued by firm2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70942-12170942-121-11DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70942-12170942-121-11DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 Butlers Hemorrhoid and Fissure
Brand name suffix
External Pain Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366789Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d92f22a7-c0b5-d8b8-e053-2a95a90a2376Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-121-01Doctor Butlers Hemorrhoid and FissureExternal Pain Formula28 g in 1 TUBECREAM286
70942-121-07Doctor Butlers Hemorrhoid and FissureExternal Pain Formula21.3 g in 1 TUBECREAM21.36
70942-121-11Doctor Butlers Hemorrhoid and FissureExternal Pain Formula28 g in 1 TUBECREAM286
70942-121-42Doctor Butlers Hemorrhoid and FissureExternal Pain Formula42.5 g in 1 JARCREAM42.56
70942-121-75Doctor Butlers Hemorrhoid and FissureExternal Pain Formula1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70942-121-75GM - Gram70942-121efda28e4-def8-4819-8716-64ddc2e1bd6b12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70942-121DOCTOR BUTLERS HEMORRHOID AND FISSURE EXTERNAL PAIN FORMULA (LIDOCAINE 5%) OINTMENT [BEYOND HEALTH, P.A.]2Current NDC, 5 package rows20241217_d92f22a7-c0b5-d8b8-e053-2a95a90a2376.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 14 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
application number: M015
Bunnies Bum Anorectal NumbingLIDOCAINEFloCal Distributors LLC3712e151-d171-1c5d-e063-6294a90a36c02025-06-08WarningsExact identifier
application number: M015
RECOVERY NumbingLIDOCAINE HCLRenu Laboratories, LLCe4e05cae-56a6-b2b3-e053-2a95a90a104b2025-06-06WarningsExact identifier
application number: M015
Hemorrohoid Master CreamLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.36eccc74-107e-3914-e063-6294a90a18562025-06-06WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc36c9988b-9e61-ebbf-e063-6394a90a41142025-06-04WarningsExact identifier
application number: M015
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.36caf20d-116a-f86a-e063-6294a90a7b622025-06-04WarningsExact identifier
application number: M015
Quick NumbLIDOCAINEClinical Resolution Laboratory, Inc.351b95a6-e038-d9aa-e063-6294a90a41722025-05-29WarningsExact identifier
application number: M015
Dibucaine Topical Anesthetic 1% HemorrhoidalDIBUCAINERugby Laboratories Inc.f23c8cd1-98f9-41cd-84d4-cf01c2ede29a2025-05-29WarningsExact identifier
application number: M015
The Femme Fix Hemorrhoid TreatmentLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLC5217b5d9-b835-4428-a6b3-e6b2556307422025-05-27WarningsExact identifier
application number: M015
MAXOCAINE Topical Anesthetic AnorectalLIDOCAINEPRIME COMMERCE, LLC26e8c867-8cb8-4a25-91b1-da45a1edd09a2025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINEEbanel Laboratories, Inc.35107403-55ae-c627-e063-6394a90a0b5c2025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc350e4d5e-dac7-ae4e-e063-6394a90a76b42025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINE 5%Ebanel Laboratories, Inc350fd302-8fd5-5288-e063-6294a90aa3822025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc35095bed-0e91-c44a-e063-6294a90add6e2025-05-27WarningsExact identifier
application number: M015
Numb520LIDOCAINEClinical Resolution Laboratory, Inc.a0411950-c6ee-4427-acb6-3cef58b0e93e2025-05-15WarningsExact identifier
application number: M015
Numb25LIDOCAINEClinical Resolution Laboratory, Inc.cfcb839d-47b4-4925-bb30-97b64d20d2b32025-05-15WarningsExact identifier
application number: M015
Numb520LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEClinical Resolution Laboratory, Inc.65d3b614-361d-4fb9-9583-a95be754bc822025-05-15WarningsExact identifier
application number: M015
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
application number: M015
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC96d2e0e7-2de0-4660-9ffd-9edb2ad224d82025-04-18WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSNd92f22a7-c0b5-d8b8-e053-2a95a90a23766
1366789lidocaine 50 MG/ML Rectal CreamSCDd92f22a7-c0b5-d8b8-e053-2a95a90a23766
1366789lidocaine 5 % Rectal CreamSYd92f22a7-c0b5-d8b8-e053-2a95a90a23766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70942-121-017094201210128 g in 1 TUBE (70942-121-01) 28 g2022-03-01NoNoCurrent
70942-121-077094201210721.3 g in 1 TUBE21.3 gHistorical
70942-121-117094201211128 g in 1 TUBE28 gHistorical
70942-121-427094201214242.5 g in 1 JAR (70942-121-42) 42.5 g2022-03-01NoNoCurrent
70942-121-75709420121751 TUBE in 1 CARTON (70942-121-75) / 21.3 g in 1 TUBE (70942-121-07) 1 tube2025-07-22NoNoCurrent