TopCare Calagesic

Product NDC: 36800-268
11-digit product format: 368000268
Labeler code: 36800
Product ID: 36800-268_0ccb3962-d499-0a6c-e063-6294a90a0d41
Type: HUMAN OTC DRUG
Nonproprietary name: calamine and pramoxine hydrochloride lotion
Dosage form: LOTION
Route: TOPICAL
Labeler: TOPCO ASSOCIATES LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-16
Substance: ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength: 80; 10 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: TopCare Calagesic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	80 mg/mL
PRAMOXINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1234532	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8dced3ea-147b-3d46-e053-2a95a90aa1c0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-268-96	TopCare Calagesic	177 mL in 1 CONTAINER	LOTION	177		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-268	TOPCARE CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION) LOTION [TOPCO ASSOCIATES LLC]	5	Current NDC, Legacy NDC, 1 package rows	20231219_8dced3ea-147b-3d46-e053-2a95a90aa1c0.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 22 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum	WHITE PETROLATUM	Harris Teeter	de380df6-cc6e-4b2a-98de-fc08eeb6e8ea	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Hy-Vee, Inc.	45867f42-9562-c111-e063-6394a90adb70	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Lidl US, LLC	c82f236d-c27f-458c-bcd8-19877d09e9a3	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Lidl US, LLC	5e83811f-773f-43e7-bab8-f9e558fb0e00	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Major Pharmaceuticals	c25be68d-834a-4959-8d47-01ec789406ba	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Major Pharmaceuticals	0e7e11c5-a1f8-43c4-b8a6-211491052404	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d76e116f-4b22-4633-8487-17ad3b5778c7	2026-02-04	Warnings	Exact identifier application number: M016
Comforts Petroleum Jelly	WHITE PETROLATUM	KROGER	3feb3638-1cdc-62d4-e063-6294a90a1d89	2026-02-03	Warnings	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	CVS Pharmacy, Inc.	edc20df4-561e-486f-b9f1-900672a0f2a4	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	CVS Pharmacy, Inc.	a153842c-d9ce-4658-912b-362a6f20b0aa	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Demoulas Super Markets, Inc	702215f0-4cfd-4a23-b47a-da691c136634	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Neurexa	COLLOIDAL OATMEAL	METHODIQ INC.	494d7915-acad-260e-e063-6394a90a182c	2026-02-03	Warnings	Exact identifier application number: M016
Thera Plus Vitamin A and D Cream	DIMETHICONE, ZINC OXIDE	FOURSTAR GROUP USA, INC.	36f09fa4-a3b8-4104-9745-ee60aa493b06	2026-02-02	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Kroger Co.	b4aa9b58-d95e-4dac-9a34-213482e8ca34	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M016
Nail Nourishing Pen	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	49e45462-a05f-d370-e063-6394a90a1e0f	2026-02-02	Warnings	Exact identifier application number: M016
Barrier Repair Cream	CREAM	Steel City Health Private Limited	4842f653-7137-eca4-e063-6394a90a8c55	2026-01-31	Warnings	Exact identifier application number: M016
Cracked Heel Repair Balm	DIMETHICONE	Delta Brands Inc.	42b7c9f8-0557-8e33-e063-6394a90a5919	2026-01-30	Warnings	Exact identifier application number: M016
Readybath TPC Total Perineal Care	DIMETHICONE	Medline Industries, Inc.	43a3f0f7-f76f-434d-a21f-7eaa3638913d	2026-01-30	Warnings	Exact identifier application number: M016
Lanolin, Petrolatum	LANOLIN, PETROLATUM	Rite Aid Corporation	1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Rite Aid Corporation	3af9f0e5-0d79-4178-b29e-3b60735bf4ce	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234532	calamine 8 % / pramoxine HCl 1 % Topical Lotion	PSN	8dced3ea-147b-3d46-e053-2a95a90aa1c0	5
1234532	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	8dced3ea-147b-3d46-e053-2a95a90aa1c0	5
1234532	calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion	SY	8dced3ea-147b-3d46-e053-2a95a90aa1c0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-268-96	36800026896	177 mL in 1 CONTAINER (36800-268-96)	177 ml	2019-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care Calagesic Lotion	TOPCO ASSOCIATES LLC \| Pharma Nobis, LLC	2023-12-18	HUMAN OTC DRUG LABEL	5