Calamine Plus Pramoxine HCl
- Product NDC
- 36800-398
- 11-digit product format
- 368000398
- Labeler code
- 36800
- Product ID
- 36800-398_5c529fcd-903f-5e7d-e063-6394a90a3155
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine Plus Spray
- Dosage form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Labeler
- Topco Associates LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-01-01
- Substance
- FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Calamine Plus Pramoxine HCl
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | .345 mg/116g |
| ZINC OXIDE | 24.16 mg/116g |
| PRAMOXINE HYDROCHLORIDE | 2.72 mg/116g |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-398-41 | Calamine Plus Pramoxine HCl | 116 g in 1 CANISTER | AEROSOL, SPRAY | 116 | 11 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CVS Health Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE | Natural Essentials, Inc. | f7198485-3d68-41d2-b9b9-f932a0649310 | 2024-12-04 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | 364924d3-fac3-4f4e-9b40-decd4ec48245 | 2024-12-03 | Warnings | M017 |
| Bite and Itch | DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE | Weeks & Leo Co., Inc. | 0a4d471b-c3f3-0a6a-e063-6394a90ad57b | 2024-12-03 | Warnings | M017 |
| Menthol | AMISH ORIGINS MEDICATED | Amish Origins LLC | 547abe39-3af3-4d70-99dd-caf8d67feda2 | 2024-12-03 | Warnings | M017 |
| Meijer Small Cold-Hot Medicated Patches | MENTHOL | Meijer Distribution Inc | be6012d6-2062-45ba-8fc4-abf14cff5845 | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | acdd5622-a9a7-4cc3-877e-57efea23303f | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5 | 2024-12-03 | Warnings | M017 |
| Salonpas DEEP Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu America, Inc. | a4ddb2b9-d023-4c8c-9285-93d51f93207d | 2024-12-03 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | ea5b4a7f-d47d-4dbd-9288-c01329e387e5 | 2024-12-03 | Warnings | M017 |
| Hempvana Ultra Strength Pain Relief - Overnight | LIDOCAINE | Telebrands Corp | 1030d478-6805-6579-e063-6294a90a0c76 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Cold Sore Treatment | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Antiseptic | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 82edaef0-0709-4ae1-a664-c9c5adb91ee1 | 2024-12-02 | Warnings | M017 |
| Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On | THERMACARE CAPSAICIN ROLL ON | Clarion Brands LLC | 2850f7e7-41dd-f5f9-e063-6394a90ae519 | 2024-12-02 | Warnings | M017 |
| BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 2ec1cf79-c341-4b79-9047-ce29f0dff419 | 2024-11-29 | Warnings | M017 |
| TheraCare Pain Relieving Lidocaine Cream | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 242204d3-efc7-f7a9-e063-6294a90a5af1 | 2024-11-27 | Warnings | M017 |
| Walgreens Flexible Pain Relieving Lidocaine | LIDOCAINE, MENTHOL | Walgreen Co. | 6f070fa3-a61a-4523-a470-ab58bf9400a3 | 2024-11-27 | Warnings | M017 |
| Benadryl Original Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 920c50cb-9bdd-4a36-bb3d-c2559db73327 | 2024-11-26 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 884907a8-c884-4cce-ac10-9d4848fdba3e | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 7f067e95-e01c-4b9a-a02e-0af097beb18c | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 9ece9b3a-0092-4c1c-a913-c2fefcd70541 | 2024-11-22 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1544717 | calamine 8 % / pramoxine HCl 1 % Topical Spray | PSN | af314adb-bd65-4233-b7e1-6cfb819615a3 | 11 |
| 1544717 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray | SCD | af314adb-bd65-4233-b7e1-6cfb819615a3 | 11 |
| 1544717 | calamine 8 % / pramoxine hydrochloride 1 % Topical Spray | SY | af314adb-bd65-4233-b7e1-6cfb819615a3 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-398-41 | 36800039841 | 116 g in 1 CANISTER (36800-398-41) | 116 g | 2017-01-01 | 0000-00-00 | No | No | Current |