FDA.reportPublic FDA data

Sunburn Relief

Product NDC
11822-0776
11-digit product format
118220776
Labeler code
11822
Product ID
11822-0776_499eab19-cf92-dfcd-e063-6294a90acc1d
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl 0.5%
Dosage form
GEL
Route
TOPICAL
Labeler
Rite Aid Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-30
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 mg/g
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
Sunburn Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 mg/g

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
1011849Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b67af0c7-1ae8-4494-bb0e-d7f66ebca352Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0776-3Sunburn Relief226 g in 1 BOTTLE, PLASTICGEL2267

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0776SUNBURN RELIEF (LIDOCAINE HCL 0.5%) GEL [RITE AID]6Current NDC, Legacy NDC, 1 package rows20250409_b67af0c7-1ae8-4494-bb0e-d7f66ebca352.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 118 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tiger BalmMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.51293a06-5922-4072-ae14-afaba9c1b58e2024-11-14WarningsExact identifier
application number: M017
Tylenol Precise Warming Pain RelievingLIDOCAINEKenvue Brands LLC0c60b607-ade9-68f2-e063-6394a90a40252024-11-13WarningsExact identifier
application number: M017
Tylenol Precise Pain RelievingLIDOCAINEKenvue Brands LLCfc1e0451-8c84-729e-e053-6394a90aaba02024-11-13WarningsExact identifier
application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
application number: M017
TopCare Pain Relieving Roll-On Topical AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLC48589893-ca67-471d-88bc-92014295ab9f2024-11-13WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Plus Topical AnalgesicMENTHOLReal Time Products Inc.fc509a55-594d-4d44-87db-33286e9375812024-11-12WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAcme United Corporationf1f051ad-7e82-9d1a-e053-2a95a90ac7d32024-11-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEALLIED TRADE LINK LLC26bc238d-3bda-0c29-e063-6394a90a35fb2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAcme United Corporationfabcaa3b-d189-bd29-e053-6294a90ae86b2024-11-12WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8414aea2-52b5-4221-e053-2a91aa0a622e2024-11-12WarningsExact identifier
application number: M017
Pain Relieving Gel-PatchLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.26c7116f-c86d-8752-e063-6294a90ab73f2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEKroger Companyfc1677f2-4078-4ebd-9c3b-86a29a35b4892024-11-12WarningsExact identifier
application number: M017
CVS Health Lidocaine CreamLIDOCAINECVS Healthad950680-c03c-4fa5-aa7f-239a889cd0972024-11-12WarningsExact identifier
application number: M017
CVS Arthritis Pain ReliefARTHRITIS PAIN RELIEFCVS Health575dd514-fd99-4e44-8fc8-52938f9abc262024-11-11WarningsExact identifier
application number: M017
ThermaPatch (TM) Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.26769590-cd50-1b01-e063-6394a90a445c2024-11-09WarningsExact identifier
application number: M017
DG Health Cold Zone Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc22594ab8-9a4a-426f-aced-5c636620fa2c2024-11-08WarningsExact identifier
application number: M017
Peviderm Pramoxine Hydrocholride 1%PRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals Inc680b40fa-1922-443a-a4b0-7c3f6a2b847d2024-11-07WarningsExact identifier
application number: M017
Meijer Analgesic with Aloe Topical AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Incf6c1e09e-4c61-4c2a-87d7-b052ed36fcac2024-11-07WarningsExact identifier
application number: M017
Meijer Pain Relieving Balm AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Inc1b7535cc-01ac-49f0-9889-dd14b254d4ae2024-11-07WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011849lidocaine HCl 0.5 % Topical GelPSNb67af0c7-1ae8-4494-bb0e-d7f66ebca3527
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCDb67af0c7-1ae8-4494-bb0e-d7f66ebca3527
1011849lidocaine hydrochloride 0.5 % Topical GelSYb67af0c7-1ae8-4494-bb0e-d7f66ebca3527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0776-311822077603226 g in 1 BOTTLE, PLASTIC (11822-0776-3) 226 g2019-12-300000-00-00NoNoCurrent