ANTIBACTERIAL COOLING BREEZE
- Product NDC
- 83033-0100
- Requested package NDC
- 83033-0100-1
- 11-digit product format
- 830330100
- Labeler code
- 83033
- Product ID
- 83033-0100_2b35d8bb-ad0c-90e2-e063-6394a90aa9d2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GLYCERIN
- Dosage form
- SOAP
- Route
- TRANSDERMAL
- Labeler
- Quimicas Handal de Centroamerica SA de CV
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-11-11
- Substance
- GLYCERIN
- Active strength
- 1 g/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- ANTIBACTERIAL COOLING BREEZE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLYCERIN | 1 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PDC6A3C0OX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 09f73bec-516d-90f0-e063-6394a90aecab | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83033-0100-1 | ANTIBACTERIAL COOLING BREEZE | 500 g in 1 BOTTLE, WITH APPLICATOR | SOAP | 500 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83033-0100 | ANTIBACTERIAL DREAMY FLORALS (GLYCERIN) SOAP ANTIBACTERIAL FRUITY ZEST (GLYCERIN) SOAP ANTIBACTERIAL COOLING BREEZE (GLYCERIN) SOAP ANTIBACTERIAL DELIGHTFUL SWEETNESS (GLYCERIN) SOAP ANTIBACTERIAL BOLD CITRUS (GLYCERIN) SOAP [QUIMICAS HANDAL DE CENTROAMERICA SA DE CV] | 2 | Current NDC, 1 package rows | 20250110_09f73bec-516d-90f0-e063-6394a90aecab.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sunmark Phenolated Calamine | CALAMINE AND ZINC OXIDE AND PHENOL | Strategic Sourcing Services LLC | 8e68efc4-4c95-41c0-9fed-32297b1b2edc | 2023-12-19 | Warnings | M016 |
| Calm and Heal Melting Balm | ALLANTOIN | The Honest Company, Inc. | b08a1bd6-986d-9520-e053-2995a90a865e | 2023-12-19 | Warnings | M016 |
| TopCare Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION | TOPCO ASSOCIATES LLC | 8dced3ea-147b-3d46-e053-2a95a90aa1c0 | 2023-12-18 | Warnings | M016 |
| TopCare Calamine | CALAMINE 8% AND ZINC OXIDE 8% LOTION | TOPCO ASSOCIATES LLC | 8dcf134e-0427-0c43-e053-2995a90a7c26 | 2023-12-18 | Warnings | M016 |
| HEB Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d576794-88d1-484a-e053-2991aa0aa479 | 2023-12-18 | Warnings | M016 |
| Publix Calamine Medicated | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673 | 2023-12-18 | Warnings | M016 |
| TopCare Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | TOPCO ASSOCIATES LLC | 8dce8817-b905-4064-e053-2995a90a071e | 2023-12-18 | Warnings | M016 |
| Assured Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Greenbriar International | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 2023-12-18 | Warnings | M016 |
| HEB Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d579680-6bcb-1161-e053-2991aa0aead1 | 2023-12-18 | Warnings | M016 |
| Publix Clear Anti-Itch | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6b905f-ed30-1ab7-e053-2a91aa0a816b | 2023-12-18 | Warnings | M016 |
| Humco Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Humco Holding Group, Inc. | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 2023-12-15 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Humco Holding Group, Inc | a3816729-be2b-4b4f-a609-953576cd2e3b | 2023-12-15 | Warnings | M016 |
| Humco Mineral Oil Light | MINERAL OIL | Humco Holding Group, Inc. | 753f35c3-1420-4817-ba63-b737a9c99a1d | 2023-12-15 | Warnings | M016 |
| Humco Witch Hazel | WITCH HAZEL | Humco Holding Group, Inc. | 3cf07016-a129-49ca-8fad-b67dda5aa009 | 2023-12-15 | Warnings | M016 |
| Rite Aid Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Rite Aid Corporation | 5df71189-9b36-9dee-e053-2a91aa0a9e49 | 2023-12-15 | Warnings | M016 |
| GNP Witch Hazel | WITCH HAZEL | Amerisource Bergen | 45ac839d-215d-4c5f-8ae5-5e111d170061 | 2023-12-14 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant | GLYCERIN | L'Oreal USA Products Inc | 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief | OATMEAL | COSMETIQUE ACTIVE PRODUCTION | e555de17-9b42-4125-a17b-467bc1d179d7 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief | OATMEAL | L'Oreal USA Products Inc | f7b71606-0044-4729-82e8-4514331806a0 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 | GLYCERIN | Cosmetique Active Production | 01c8a0d5-bcd1-4639-be45-530a226401f0 | 2023-12-11 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83033-0100-1 | 83033010001 | 500 g in 1 BOTTLE, WITH APPLICATOR (83033-0100-1) | 500 g | 2022-11-11 | No | No | Current |