Orajel Instant Pain Relief For All Mouth Sores

Product NDC
65734-503
Requested package NDC
65734-503-12
11-digit product format
657340503
Labeler code
65734
Product ID
65734-503_c28d37ef-bad0-cb2c-e053-2a95a90a87d9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Swabplus, L.P.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65734-503-126573405031212 APPLICATOR in 1 CARTON (65734-503-12) > .15 g in 1 APPLICATOR12 applicator2019-01-010000-00-00NoNoCurrent