Calprotect

Product NDC: 69618-067
11-digit product format: 696180067
Labeler code: 69618
Product ID: 69618-067_4b32706a-c97a-589c-e063-6294a90abc11
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol, Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Reliable 1 Laboratories LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-01-01
Substance: ZINC OXIDE; MENTHOL
Active strength: 20.6; .44 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	69618-067		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69618-067	69618-067-82	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69618-067	69618-067-71	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: Calprotect
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	20.6 g/100g
MENTHOL	.44 g/100g

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
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2123045	Internal RxNorm lookup
2702497	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
09fb2810-0cc1-b2e2-e063-6294a90a4576	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-067-71	Calprotect	71 g in 1 JAR	OINTMENT	71		5
69618-067-82	Calprotect	113 g in 1 TUBE	OINTMENT	113		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-067-71	GM - Gram	69618-067	4d28b714-56c8-4898-a629-9c8e2cde2843	1	2023-12-05
69618-067-82	GM - Gram	69618-067	2549dd69-0e5c-435a-aa71-3b84f4ead935	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-067	CALPROTECT (MENTHOL, ZINC OXIDE) OINTMENT [RELIABLE 1 LABORATORIES LLC]	4	Current NDC, 2 package rows	20250121_09fb2810-0cc1-b2e2-e063-6294a90a4576.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 1 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flarestop Hemorrhoid Lidocaine	LIDOCAINE	Chelsea Pharmacceuticals LLC	b8a589f7-7131-4807-9bcb-84af3078e258	2026-09-10	Warnings	Exact identifier application number: M015
BCBCYC Numbing Cream	LIDOCAINE 5% NUMBING CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5ab36566-ba2f-06ef-e063-6394a90a71b5	2026-09-10	Warnings	Exact identifier application number: M015
5% Lidocaine 10g	5% LIDOCAINE	Chongqing Mandongzi Technology Co., Ltd	5b10530f-47cd-c4bd-e063-6294a90aaa0a	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Rite Aid Corporation	407c78ca-6fee-4ed6-b61b-711ec049c86e	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	CVS Pharmacy	3167c918-a7d3-46a1-a85b-64f9c22916f2	2026-09-04	Warnings	Exact identifier application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum Strength	WITCH HAZEL	Amazon.com Services LLC	41d756f3-e523-ed14-e063-6394a90ab817	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel	HEMORRHOIDAL WIPES WITH WITCH HAZEL	Better Living Brands LLC	adf26111-70ba-596c-e053-2995a90ac6f1	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
up and up medicated wipes manixim strength	GENTLE HEMORRHOIDAL CARE	Target Corporation	271eab2b-ed13-39f1-e054-00144ff88e88	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE	WITCH HAZEL CLOTH	The Kroger Co.	48c1598d-6667-446f-ac90-10ab945d0617	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel	WITCH HAZEL	Old East Main Co.	2055289d-962e-46a9-b371-b5bb93dd46b4	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Equate Hemorrhoidal Medicated Wipes	WITCH HAZEL	Walmart Inc.	8d57f054-77dc-4205-85f1-b65dcfde677b	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Lidocaine Cream	LIDOCAINE	InvaDerm Corporation	5a7273d1-1dbc-420e-e063-6294a90a8629	2026-09-01	Warnings	Exact identifier application number: M015
Lidocaine Phenylephrine	LIDOCAINE PHENYLEPHRINE	YYBA CORP	5a72a190-2129-411e-e063-6394a90a08c2	2026-09-01	Warnings	Exact identifier application number: M015
INICEI 5% LIDOCAINE Numbing Cream	5% LIDOCAINE NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5a65842f-27a1-268b-e063-6294a90a6054	2026-08-31	Warnings	Exact identifier application number: M015
AnievaLC	LIDOCAINE	Blackstone Products, LLC	ddaba14c-10de-44e2-ae13-9217e20cb48e	2026-08-29	Warnings	Exact identifier application number: M015
Norms Hemorrhoid Wipes	WITCH HAZEL	Totally Normal Company	5a1af50b-8d00-f589-e063-6394a90af86c	2026-08-28	Warnings	Exact identifier application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	59f0fa16-5eb0-e6bb-e063-6294a90aacf5	2026-08-26	Warnings	Exact identifier application number: M015
Dude Hemorrhoidal Wipes	WITCH HAZEL	Dude Products	fdf408ef-9392-a812-e053-6394a90a0017	2026-08-25	Warnings	Exact identifier application number: M015
Norms Medicated Wipes	WITCH HAZEL	Totally Normal Company	3a78e109-3f7c-fb19-e063-6394a90ae78e	2026-08-22	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	599b425a-0e96-76df-e063-6394a90a48ff	2026-08-21	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2702497	CalProtect 0.44 % / zinc oxide 20.6 % Topical Ointment	PSN	09fb2810-0cc1-b2e2-e063-6294a90a4576	5
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	PSN	09fb2810-0cc1-b2e2-e063-6294a90a4576	5
2702497	menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calprotect]	SBD	09fb2810-0cc1-b2e2-e063-6294a90a4576	5
2123045	menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment	SCD	09fb2810-0cc1-b2e2-e063-6294a90a4576	5
2702497	Calprotect (menthol 0.44 % / zinc oxide 20.6 % ) Topical Ointment	SY	09fb2810-0cc1-b2e2-e063-6294a90a4576	5
2123045	Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment	SY	09fb2810-0cc1-b2e2-e063-6294a90a4576	5
2702497	menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calprotect]	SY	09fb2810-0cc1-b2e2-e063-6294a90a4576	5
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	SY	09fb2810-0cc1-b2e2-e063-6294a90a4576	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69618-067-71	69618006771	71 g in 1 JAR (69618-067-71)	71 g	2021-01-01	No	No	Current
69618-067-82	69618006782	113 g in 1 TUBE (69618-067-82)	113 g	2021-01-01	No	No	Current