Calamine Phenolated Topical Suspension

Product NDC: 82645-921
11-digit product format: 826450921
Labeler code: 82645
Product ID: 82645-921_0d6ccb8f-d9bf-28e6-e063-6294a90a8a87
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine and Zinc Oxide and Phenol
Dosage form: LOTION
Route: TOPICAL
Labeler: Pharma Nobis, LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-01-01
Substance: PHENOL; ZINC OXIDE
Active strength: 10; 160 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
PHENOL	10 mg/mL
ZINC OXIDE	160 mg/mL

Field, Values table
Field	Values
Unii	339NCG44TV, SOI2LOH54Z
Rxcui	991369

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82645-921-96	Calamine Phenolated Topical Suspension	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82645-921	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [PHARMA NOBIS, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20231227_e42fbdcc-3291-7761-e053-2995a90a7172.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
339NCG44TV	PHENOL	108-95-2	PHENOL
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Lotion	PSN	e42fbdcc-3291-7761-e053-2995a90a7172	2
991369	calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	e42fbdcc-3291-7761-e053-2995a90a7172	2
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Lotion	SY	e42fbdcc-3291-7761-e053-2995a90a7172	2
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Suspension	SY	e42fbdcc-3291-7761-e053-2995a90a7172	2
991369	Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	e42fbdcc-3291-7761-e053-2995a90a7172	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82645-921-96	82645092196	177 mL in 1 BOTTLE, PLASTIC (82645-921-96)	177 ml	2017-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Private Label Calamine Phenolated Topical Suspension, USP	Pharma Nobis, LLC	2023-12-26	HUMAN OTC DRUG LABEL	2