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 20 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Preparation H Cooling Gel	PHENYLEPHRINE HCL, WITCH HAZEL	Haleon US Holdings LLC	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier application number: M015
Preparation H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL	Haleon US Holdings LLC	2f370875-0225-47b7-b43f-8fa4600d2a0e	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a23ded81-78ba-c199-a8f0-aaf360b216ff	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H MEDICATED WIPES	WITCH HAZEL	Haleon US Holdings LLC	3b1cfa8a-942f-471e-b7c0-744f83b687a0	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H HYDROCORTISONE	HYDROCORTISONE	Haleon US Holdings LLC	b8d531eb-4012-0450-0e4b-70a808464041	2024-02-29	Warnings	Exact identifier application number: M015
PREPARATION H	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Haleon US Holdings LLC	507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	27db1d58-4609-4a80-af2f-9e36f10482e1	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	699310e8-1a93-40b4-a8f4-a765be4a0cb1	2024-02-29	Warnings	Exact identifier application number: M015
Numquick Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	b66e7a91-9e35-64dd-e053-2a95a90a8b83	2024-02-28	Warnings	Exact identifier application number: M015
Medicated Wipes Hemorroidal Wipes With Witch Hazel	WITCH HAZEL	Wuhan Zonsen Medical Products Co., Ltd.	12441e46-5490-d45c-e063-6394a90a39e3	2024-02-26	Warnings	Exact identifier application number: M015
Lidocaine Hemorrhoid	LIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZEL	Walgreens Co	10a47899-f4a0-66e8-e063-6394a90a11dd	2024-02-05	Warnings	Exact identifier application number: M015
ER Hemorrhoid	PHENYLEPHRINE HCL	EVER READY FIRST AID	3cf29fc0-af4d-4610-a426-894601d5e078	2024-02-02	Warnings	Exact identifier application number: M015
RRHOID RAGE Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	POPPY COLLECTIVE LLC	a02a6398-0acd-4aa7-8320-ac586ff12eb3	2024-01-31	Warnings	Exact identifier application number: M015
No More Products	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc	102e7dbb-06dc-f4d1-e063-6394a90aa3eb	2024-01-26	Warnings	Exact identifier application number: M015
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc.	0fe10710-ac59-4fc5-e063-6294a90a48fc	2024-01-26	Warnings	Exact identifier application number: M015
Prosoria Anti-Itch Moisturizer	PRAMOXINE HYDROCHLORIDE	Nuvothera, Inc.	3c4b9515-f435-4227-a347-d6508778426d	2024-01-10	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Cardinal Health 110 dba LEADER	a5a261c2-1f36-c895-e053-2a95a90ab22b	2024-01-02	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Proficient Rx LP	105095e3-843e-4153-adc9-266dd14929a2	2024-01-01	Warnings	Exact identifier application number: M015
Family Wellness HEMORRHOID	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	FAMILY DOLLAR (Family Wellness)	16ceb129-5c0a-428a-a867-cfbbb08bb62a	2023-12-11	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