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 18 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoid Pain Relief	LIDOCAINE	Telebrands Corp	04164425-ca3b-ef24-e063-6294a90a59d8	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic	LIDOCAINE	Telebrands Corp	f525075a-d7ee-dad0-e053-2a95a90a6f3f	2024-11-20	Warnings	Exact identifier application number: M015
Curist Lidocaine Numbing Relief	LIDOCAINE	Little Pharma, Inc.	bff3c422-a0df-6196-e053-2a95a90af033	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum	LIDOCAINE 5%	Telebrands Corp	2774ec41-7366-ac8c-e063-6394a90a1ee2	2024-11-20	Warnings	Exact identifier application number: M015
Walgreens Anorectal Lidocaine Cream	5% LIDOCAINE	Walgreens Company	3052fac7-fd68-43f4-9950-8c07288a6b6d	2024-11-20	Warnings	Exact identifier application number: M015
Lidocaine Anorectal	LIDOCAINE	Patrin Pharma, Inc	456d41fe-8449-4980-9291-d7a3b65a900d	2024-11-13	Warnings	Exact identifier application number: M015
MyDerm	PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,	Inspec Solution LLC.	2618eba1-9308-a666-e063-6394a90ac3d2	2024-11-04	Warnings	Exact identifier application number: M015
Granulotion Medicated	MENTHOL, ZINC OXIDE	GL HEALTH, INC.	01701780-b160-415b-b34d-362237179475	2024-10-29	Warnings	Exact identifier application number: M015
rexall hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Dolgencorp Inc	0415c51b-5a12-49d4-8968-0131ddb85545	2024-10-23	Warnings	Exact identifier application number: M015
Exchange Select Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Army & Air Force Exchange Service	8155ed74-9412-498f-998c-4a29c46e934f	2024-10-23	Warnings	Exact identifier application number: M015
Leader Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	c4814524-0f4c-4351-a431-5b4b6431fd28	2024-10-23	Warnings	Exact identifier application number: M015
basic care hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Amazon.com Services LLC	617d9213-31f0-4c71-be0c-7961b96e5143	2024-10-23	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Safeway	e74b71a1-915d-4e5b-b548-d5cce7945dbd	2024-10-23	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	d29b7824-ff9e-4875-b3de-92721c8add0e	2024-10-23	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Publix Super Markets Inc	a241cb37-7007-4fd8-a12e-f3fc6d6f780e	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Kroger Company	d44ca22a-dc20-454d-99aa-403a8c7a3e00	2024-10-22	Warnings	Exact identifier application number: M015
rugby hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Rugby Laboratories	c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Meijer Distribution Inc	1431397e-3515-4794-a494-70667948e14c	2024-10-18	Warnings	Exact identifier application number: M015
signature care hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Safeway	afcf68cf-f187-44d3-ad91-b1e79b182bc6	2024-10-17	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	H E B	1435432d-5ff2-468b-808d-fb0c99a0717b	2024-10-17	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