FDA.reportPublic FDA data

Solarcaine Burn Pain Relief 4oz

Product NDC
65197-502
11-digit product format
651970502
Labeler code
65197
Product ID
65197-502_c455721a-9bce-42b8-a7ee-ce9d54aea4c5
Type
HUMAN OTC DRUG
Nonproprietary name
Solarcaine Burn Pain Relief 4oz
Dosage form
SPRAY
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 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

Additional Listing Data#

Finished product
Yes
Brand name base
Solarcaine Burn Pain Relief 4oz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1045432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65197-502-042025-12-03C16284748780-12cef2736-7dc3-d83d-e063-dadaa90ab31fSolarcaine Burn Pain Relief Spray 4oz
65197-502-042025-01-30C16284748780-12cef2736-7dc3-d83d-e063-dadaa90ab31fSolarcaine Burn Pain Relief Spray 4oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-502-04Solarcaine Burn Pain Relief 4oz113 g in 1 CANSPRAY1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-502SOLARCAINE BURN PAIN RELIEF 4OZ (SOLARCAINE BURN PAIN RELIEF 4OZ) SPRAY [WELLSPRING PHARMACEUTICAL CORPORATION]2Current NDC, 1 package rows20240101_14f23c28-c713-4868-9f46-66363bf94b2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045432lidocaine HCl 4 % Topical SprayPSN14f23c28-c713-4868-9f46-66363bf94b2c4
1045432lidocaine hydrochloride 40 MG/ML Topical SpraySCD14f23c28-c713-4868-9f46-66363bf94b2c4
1045432lidocaine HCl 4 % Topical SpraySY14f23c28-c713-4868-9f46-66363bf94b2c4
1045432lidocaine HCl 4 % Topical Spray GelSY14f23c28-c713-4868-9f46-66363bf94b2c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-502-0465197050204113 g in 1 CAN (65197-502-04) 113 g2024-01-01NoNoHistorical