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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Meijer Distribution Inc	14319ba4-3bce-497c-a380-65bd24defc5d	2024-10-17	Warnings	Exact identifier application number: M015
equate hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	581dd76f-d052-4448-8139-9a2e31891b25	2024-10-17	Warnings	Exact identifier application number: M015
Equate Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	81ecb091-38da-4b3e-a0a1-b4986b97ee09	2024-10-16	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	5c81d564-f786-46e1-af8b-f47521fbae60	2024-10-16	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Topco Associates LLC	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	2024-10-16	Warnings	Exact identifier application number: M015
Basic Care Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Amazon.com Services LLC	fe675174-fc95-4dd7-bd39-c209c6ce0f6c	2024-10-16	Warnings	Exact identifier application number: M015
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Meijer Distribution Inc	fb170371-2e5d-43ca-a259-538a973ee3b8	2024-10-15	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Topco Associates LLC	5e13da07-48cf-40bc-bb11-fd891886cbea	2024-10-14	Warnings	Exact identifier application number: M015
hemorrhoidal maximum strength pain relief	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Kroger Company	3c8f90e2-fecf-4439-9faa-81a32ffe4753	2024-09-26	Warnings	Exact identifier application number: M015
equate hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Wal-Mart Stores Inc	5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d	2024-09-26	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal Pain Relief	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Walgreens	e79ed7ae-0d06-2f88-e053-2995a90a1e35	2024-09-20	Warnings	Exact identifier application number: M015
hemorrhoidal relief	COCOA BUTTER, PHENYLEPHRINE HCL	Rite Aid Corporation	ddafbdca-32c2-49c1-83d3-35b4155958c9	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Rite Aid Corporation	8e1f223a-a3a0-4837-9847-2a3939fcc595	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bryant Ranch Prepack	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2024-08-14	Warnings	Exact identifier application number: M015
Up and Up Hemorrhoid MAX STRENGTH	14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUM	Target Corporation	867677b5-fd1d-449e-966e-1de0b5c98afb	2024-08-08	Warnings	Exact identifier application number: M015
Soothing Hemorrhoidal Wipes 50 Witch Hazel	WITCH HAZEL	The Honey Pot Company LLC	1ea202f5-e228-b3f2-e063-6294a90a16c1	2024-08-01	Warnings	Exact identifier application number: M015
Bunnies Bum Hemorrhoidal Numbing	LIDOCAINE	FloCal Distributors LLC	1c809643-0cbe-568f-e063-6394a90a3210	2024-07-05	Warnings	Exact identifier application number: M015
Bunnies Bum Soothing Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	FloCal Distributors LLC	1c81582c-7ece-182f-e063-6294a90a8fbc	2024-07-05	Warnings	Exact identifier application number: M015
MegaBabe Butt Stuff Hemorrhoidal	COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	MEGABABE, LLC	01c156ff-69f9-4d5e-a9ea-abbc52d4afff	2024-06-12	Warnings	Exact identifier application number: M015
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	Advanced Rx LLC	f4f89582-49e6-424a-bea7-0694484a7c99	2024-04-11	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