NDC 68788-9553

Berri-Freez

Menthol

Berri-Freez is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Menthol, Unspecified Form.

• Product ID: 68788-9553_c16811ab-bb61-4877-85b9-87b45f648f8f
• NDC: 68788-9553
• Product Type: Human Otc Drug
• Proprietary Name: Berri-Freez
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-10-07
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Preferred Pharmaceuticals, Inc.
• Substance Name: MENTHOL, UNSPECIFIED FORM
• Active Ingredient Strength: 5 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68788-9553-1

113 g in 1 TUBE (68788-9553-1)

• Marketing Start Date: 2013-10-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-9553-1 [68788955301]

Berri-Freez GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-10-07
• Marketing End Date: 2019-06-19

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	4.5 g/100g

OpenFDA Data

• SPL SET ID: dead7515-8312-4c37-8cd8-e47b51e7ed60
• Manufacturer:
  • Preferred Pharmaceuticals, Inc.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1313823
  • 1363900

NDC Crossover Matching brand name "Berri-Freez" or generic name "Menthol"

NDC	Brand Name	Generic Name
68788-9553	Berri-Freez	Berri-Freez
54162-002	Berri-Freez	Berri-Freez
54162-009	Berri-Freez	Berri-Freez
0363-1071	Cherry Cough Drop	Menthol
0363-1086	Cherry Cough Drops	Menthol
0363-0150	Cool n Heat Patch for Arm, Neck and Leg	Menthol
0363-0152	Cool n Heat Patch for Back	Menthol
0363-1072	Honey Lemon Cough Drop	Menthol
0363-1087	Honey Lemon Cough Drop	Menthol
0219-0203	Humphreys Bendito Alcoholado	menthol
0363-1070	Menthol Cough Drop	menthol
0363-1084	Menthol Cough Drop	menthol
0067-2067	Mineral Ice	Menthol
0316-0226	Mineral Ice	Menthol
0316-0290	Mineral Ice Quick Dry Foam	Menthol
0363-0151	Pain Relieving Patch	Menthol
0363-1077	SF Honey Lemon Cough Drop	Menthol
0363-1085	SF Menthol Cough Drop	Menthol
0363-0043	Studio 35 Medicated Body	Menthol
0363-0864	Walgreens Cold Pain Relief	MENTHOL
0363-0874	Walgreens Cold Pain Relief	MENTHOL
0363-0966	Walgreens Sunburn Relief	Menthol