FDA.reportPublic FDA data

ZyloRelief

Product NDC
87450-208
11-digit product format
874500208
Labeler code
87450
Product ID
87450-208_b51ef16a-8a2e-4241-89fc-db01917a45b2
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Highmark Pharma LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-01
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
2027-12-31
Current FDA listing
Yes

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
ZyloRelief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010895Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
635f5b98-f74c-495f-a537-686fcba9ccadAvailable on FDA.report

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 125 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017
RUGBY HYDROCORTISONE WITH ALOEHYDROCORTISONEA-S Medication Solutionsb2674075-aaa4-4c77-bcaa-a76336b3c3212024-10-02WarningsExact identifier
application number: M017
Herb Street Anti-Itch StickHYDROCORTISONEBalassa Laboratories Inc.8717faae-59c3-4c6f-9ef1-285c0d2445ed2024-10-01WarningsExact identifier
application number: M017
Herb Street Backache and Sore Muscle ReliefMENTHOLBalassa Laboratories Inc.aeac1b64-8689-4b3d-a41c-db41061257b52024-10-01WarningsExact identifier
application number: M017
Herb Street Arthritis ReliefMENTHOL/CAMPHORBalassa Laboratories Inc.a9d8ceb7-def0-415f-8fc1-ff8dd3e418552024-10-01WarningsExact identifier
application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-PatchLIDOCAINEGalaxy Bio, Inc.2243734a-4ea2-a5e5-e063-6294a90aba152024-10-01WarningsExact identifier
application number: M017
Medicated Herbal Lip BalmMENTHOLEarth Mama Angel Baby LLC1cc2391e-6a7a-609c-e063-6394a90a63052024-10-01WarningsExact identifier
application number: M017
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
application number: M017
CircataCAPSAICINPureTek Corporationb67161d7-cc5c-e971-e053-2995a90acbe72024-10-01WarningsExact identifier
application number: M017
MenticamCAMPHOR,MENTHOL, METHYL SALICYLATEPureTek Corporationffea2e97-777f-434b-e053-6394a90a3a632024-10-01WarningsExact identifier
application number: M017
Herb Street Sore Muscle ReliefMETHYL SALICYLATEBalassa Laboratories Inc.e43943c2-d4cd-44c5-a0ff-403a8d42860f2024-10-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEKroger Company68dab606-0385-48b7-9a7b-a2cf83d203932024-09-29WarningsExact identifier
application number: M017
kirkland signature hydrocortisone plus maximum strengthHYDROCORTISONECostco Wholesale Company481341c5-db1f-43fb-aed7-f40495a4eab82024-09-29WarningsExact identifier
application number: M017
Care One hydrocortisone maximum strengthHYDROCORTISONEAmerican Sales Company32593229-d0ac-4d6c-831a-089fc6e761522024-09-29WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87450-208-05874500208055 PACKET in 1 CARTON (87450-208-05) / 2 g in 1 PACKET (87450-208-01) 5 packet2026-07-01NoNoCurrent