FDA.reportPublic FDA data

Burn First Aid

Product NDC
67777-007
11-digit product format
677770007
Labeler code
67777
Product ID
67777-007_0f907def-a9d1-3e58-e063-6294a90a641b
Type
HUMAN OTC DRUG
Nonproprietary name
Burn First Aid
Dosage form
CREAM
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-17
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
13; 50 mg/10000mg; mg/10000mg
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
Burn First Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE13 mg/10000mg
LIDOCAINE HYDROCHLORIDE50 mg/10000mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui1012100

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-007-49Burn First Aid900 mg in 1 PACKETCREAM9003
67777-007-49Burn First Aid144 in 1 BOXCREAM1443
67777-007-50Burn First Aid1728 in 1 CASECREAM17283
67777-007-51Burn First Aid10 in 1 BOXCREAM103
67777-007-51Burn First Aid900 mg in 1 PACKETCREAM9003
67777-007-52Burn First Aid1000 in 1 CASECREAM10003
67777-007-53Burn First Aid25 in 1 BOXCREAM253
67777-007-53Burn First Aid900 mg in 1 PACKETCREAM9003
67777-007-54Burn First Aid1800 in 1 CASECREAM18003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-007BURN FIRST AID CREAM [DYNAREX CORPORATION]3Current NDC, Legacy NDC, 9 package rows20240124_826e08be-dffa-5a27-e053-2a91aa0a8701.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN826e08be-dffa-5a27-e053-2a91aa0a87013
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD826e08be-dffa-5a27-e053-2a91aa0a87013
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY826e08be-dffa-5a27-e053-2a91aa0a87013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-007-4967777000749900 mg in 1 PACKET900 mgHistorical
67777-007-50677770007501728 BOX in 1 CASE (67777-007-50) / 144 PACKET in 1 BOX (67777-007-49) / 900 mg in 1 PACKET1728 box2018-09-170000-00-00NoNoCurrent
67777-007-516777700075110 in 1 BOXHistorical
67777-007-52677770007521000 BOX in 1 CASE (67777-007-52) / 10 PACKET in 1 BOX (67777-007-51) / 900 mg in 1 PACKET1000 box2018-09-17NoNoCurrent
67777-007-536777700075325 in 1 BOXHistorical
67777-007-54677770007541800 BOX in 1 CASE (67777-007-54) / 25 PACKET in 1 BOX (67777-007-53) / 900 mg in 1 PACKET1800 box2018-09-17NoNoCurrent