Home NDC 10237-731 Orajel Rescue Relief Pen
Product NDC 10237-731
11-digit product format 102370731
Labeler code 10237
Product ID 10237-731_38d791e8-33d3-22e4-e063-6394a90aff90
Type HUMAN OTC DRUG
Nonproprietary name Oral Pain Reliever
Dosage form GEL
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-01
Substance ZINC CHLORIDE; MENTHOL; BENZOCAINE
Active strength 1.5; 2.6; 200 mg/g; mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Orajel Rescue Relief Pen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC CHLORIDE 1.5 mg/g MENTHOL 2.6 mg/g BENZOCAINE 200 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 86Q357L16B Internal UNII lookup L7T10EIP3A Internal UNII lookup U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2362013 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-731-07 Orajel Rescue Relief Pen 1 in 1 BLISTER PACK GEL 1 2 10237-731-07 Orajel Rescue Relief Pen 2 g in 1 APPLICATOR GEL 2 2 10237-731-27 Orajel Rescue Relief Pen 1 in 1 BLISTER PACK GEL 1 2 10237-731-27 Orajel Rescue Relief Pen 2 in 1 PACKAGE GEL 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-731 ORAJEL RESCUE RELIEF PEN (ORAL PAIN RELIEVER) GEL [CHURCH & DWIGHT CO., INC.] 1 Current NDC, 4 package rows 20250207_2d68eec5-ae8a-9cdf-e063-6294a90a9799.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 27 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-731-07 10237073107 1 APPLICATOR in 1 BLISTER PACK (10237-731-07) / 2 g in 1 APPLICATOR 1 applicator 2025-02-01 No No Current 10237-731-27 10237073127 2 BLISTER PACK in 1 PACKAGE (10237-731-27) / 1 APPLICATOR in 1 BLISTER PACK / 2 g in 1 APPLICATOR 2 blister pack 2025-06-01 No No Current