NDC 67492-104
Calmol 4
Zinc Oxide And Cocoa Butter
Calmol 4 is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Resical Inc.. The primary component is Zinc Oxide; Cocoa Butter.
| Product ID | 67492-104_7c4d0077-3102-cb52-e053-2a91aa0a2a3b |
| NDC | 67492-104 |
| Product Type | Human Otc Drug |
| Proprietary Name | Calmol 4 |
| Generic Name | Zinc Oxide And Cocoa Butter |
| Dosage Form | Suppository |
| Route of Administration | RECTAL |
| Marketing Start Date | 2006-05-13 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Labeler Name | Resical Inc. |
| Substance Name | ZINC OXIDE; COCOA BUTTER |
| Active Ingredient Strength | 270 mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 67492-104-11
4 BLISTER PACK in 1 CARTON (67492-104-11) > 6 SUPPOSITORY in 1 BLISTER PACK
| Marketing Start Date | 2006-05-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 67492-104-13 [67492010413]
Calmol 4 SUPPOSITORY
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2006-05-13 |
NDC 67492-104-12 [67492010412]
Calmol 4 SUPPOSITORY
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2006-05-13 |
NDC 67492-104-11 [67492010411]
Calmol 4 SUPPOSITORY
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2006-05-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 270 mg/1 |
OpenFDA Data
| SPL SET ID: | 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "Calmol 4" or generic name "Zinc Oxide And Cocoa Butter"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 67492-104 | Calmol 4 | Zinc Oxide and Cocoa Butter |
| 54866-001 | AVERTEAX | zinc oxide and Cocoa Butter |
| 54866-003 | AVERTEAX | zinc oxide and Cocoa Butter |
Trademark Results [Calmol 4]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALMOL 4 72237150 0820221 Live/Registered |
CHAS. PFIZER & CO., INC. 1966-01-24 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.