FDA.reportPublic FDA data

THE SOLUTION

Product NDC
82617-101
11-digit product format
826170101
Labeler code
82617
Product ID
82617-101_2b369998-00c4-fcb6-e063-6294a90af2eb
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
SCALP TECH INC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
LIDOCAINE HYDROCHLORIDE; EPINEPHRINE HYDROCHLORIDE
Active strength
5; .01 g/100mL; g/100mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82617-101-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82617-101-140efc9e666f02…f202fb6c5f17…

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
THE SOLUTION
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 g/100mL
EPINEPHRINE HYDROCHLORIDE.01 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
WBB047OO38Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2601579Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df51623c-e0b6-8e86-e053-2995a90a59b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82617-101-14THE SOLUTION118 mL in 1 BOTTLE, SPRAYSPRAY1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82617-101THE SOLUTION (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE) SPRAY [SCALP TECH INC]4Current NDC, Legacy NDC, 1 package rows20250122_df51623c-e0b6-8e86-e053-2995a90a59b2.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
2601579EPINEPHrine HCl 0.01 % / lidocaine HCl 5 % Rectal SprayPSNdf51623c-e0b6-8e86-e053-2995a90a59b24
2601579epinephrine hydrochloride 0.1 MG/ML / lidocaine hydrochloride 50 MG/ML Rectal SpraySCDdf51623c-e0b6-8e86-e053-2995a90a59b24
2601579epinephrine hydrochloride 0.01 % / lidocaine hydrochloride 5 % Rectal SpraySYdf51623c-e0b6-8e86-e053-2995a90a59b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82617-101-1482617010114118 mL in 1 BOTTLE, SPRAY (82617-101-14) 118 ml2022-04-010000-00-00NoNoCurrent