FDA.reportPublic FDA data

American Safety First Aid

Product NDC
71927-012
11-digit product format
719270012
Labeler code
71927
Product ID
71927-012_5aebc911-05c4-d91c-e063-6294a90a8924
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Orazen Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-03
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
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
American Safety First Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

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
1010769Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea2f776b-dfd0-6ce4-e053-2995a90af009Available 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
71927-012-01American Safety First Aid59.1 mL in 1 BOTTLE, SPRAYSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-012AMERICAN SAFETY FIRST AID (LIDOCAINE HCL) SPRAY [ORAZEN INC]2Current NDC, Legacy NDC, 1 package rows20240116_ea2f776b-dfd0-6ce4-e053-2995a90af009.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 96 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pain ReliefMENTHOL 10.5%CVSd0ea80ce-38b2-acde-e053-2995a90a47e52025-03-31WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEA2A Integrated Pharmaceuticals, LLC31431866-6fb5-2acd-e063-6294a90ac5202025-03-31WarningsExact identifier
application number: M017
Citrus Cleansing Foot Soak and Body SoakCAMPHORSANSAR, LLCf136616d-9f32-4e55-a495-b7466fd685262025-03-28WarningsExact identifier
application number: M017
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
application number: M017
Muscle Recovery Foot Soak and Body SoakCAMPHORSANSAR, LLC1c347267-b653-41bf-9967-7feff17c38af2025-03-27WarningsExact identifier
application number: M017
Soothing Lavender Foot Soak and Body SoakCAMPHORSANSAR, LLCef26523a-b2f2-466e-89ad-f293cd64decb2025-03-27WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc31408e21-e58d-6db5-e063-6294a90aa4bc2025-03-26WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc3143bb72-2969-d66e-e063-6294a90a46042025-03-26WarningsExact identifier
application number: M017
Parche LeonCAPSAICIN, CAMPHOR, MENTHOLPharmadel LLCa8f266fa-6e43-559e-e053-2995a90a2c752025-03-26WarningsExact identifier
application number: M017
Adellina Numbing CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.314a83fe-8bdb-766f-e063-6294a90a61c62025-03-26WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus Menthol PatchLIDOCAINE AND MENTHOLVeridian Healthcare312f15fe-9297-2dc2-e063-6294a90a6f4d2025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3130729d-1679-90cd-e063-6294a90a21e62025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare31314dda-6199-574d-e063-6394a90aae7a2025-03-25WarningsExact identifier
application number: M017
RWSEFK Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.31366793-f8a6-a2c4-e063-6294a90acbfc2025-03-25WarningsExact identifier
application number: M017
Forticept Wounds and Burns HydrogelBENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELidan, inc.c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f2025-03-25WarningsExact identifier
application number: M017
MQ Pain Relieving PatchPAIN RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0978ff22-c357-e266-e063-6394a90a98a42025-03-24WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPFCAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.5f904369-5f21-4907-98de-df23bce308232025-03-20WarningsExact identifier
application number: M017
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010769lidocaine HCl 2 % Topical SprayPSNea2f776b-dfd0-6ce4-e053-2995a90af0092
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCDea2f776b-dfd0-6ce4-e053-2995a90af0092
1010769lidocaine hydrochloride 2 % Topical SpraySYea2f776b-dfd0-6ce4-e053-2995a90af0092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71927-012-017192700120159.1 mL in 1 BOTTLE, SPRAY (71927-012-01) 59.1 ml2022-10-030000-00-00NoNoCurrent