FDA.reportPublic FDA data

Numb520

Product NDC
63742-012
Requested package NDC
63742-012-00
11-digit product format
637420012
Labeler code
63742
Product ID
63742-012_88f39f37-e4b0-1e0e-e053-2a95a90a5cee
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Clinical Resolution Laboratory, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-05-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
50 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage63742-01263742-012-00IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63742-012-00Numb52072 mL in 1 BOTTLESPRAY722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63742-012NUMB520 (LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SPRAY [CLINICAL RESOLUTION LABORATORY, INC.]2Legacy NDC, 1 package rows20231227_d88d5250-2fc1-46da-a312-a2542e226c5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2168528lidocaine HCl 5 % / phenylephrine HCl 0.25 % Topical SprayPSNd88d5250-2fc1-46da-a312-a2542e226c5d2
2168528lidocaine hydrochloride 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Topical SpraySCDd88d5250-2fc1-46da-a312-a2542e226c5d2
2168528lidocaine hydrochloride 5 % / phenylephrine hydrochloride 0.25 % Topical SpraySYd88d5250-2fc1-46da-a312-a2542e226c5d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63742-012-006374200120072 mL in 1 BOTTLE (63742-012-00) 72 ml2019-05-010000-00-00NoNoCurrent