Humco Calamine
- Product NDC
- 0395-0413
- 11-digit product format
- 003950413
- Labeler code
- 0395
- Product ID
- 0395-0413_52b9f60d-7ae7-26c8-e063-6294a90acc20
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine 8% and Zinc Oxide 8%
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Humco holding Group, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-03-25
- Substance
- ZINC OXIDE
- Active strength
- 160 mg/mL
- 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
- Humco Calamine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 160 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 617954 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f7dcd959-fb98-43bb-8dd3-a662bf8a053c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0395-0413-96 | Humco Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0395-0413-96 | ML - Milliliter | 0395-0413 | 7388d9e7-558f-47b8-9386-b0372be86ab3 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| CALCIUM HYDROXIDE | INACTIVE INGREDIENT | PF5DZW74VN | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 |
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 |
|---|---|---|---|---|---|---|
| Find Your Happy Place | WRAPPED IN YOUR ARMS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0ef938-da18-3b9c-e053-2995a90acb72 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | SUNKISSED OCEAN WAVES HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0db6a3-222a-093f-e053-2a95a90ac88a | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | LAZY WEEKENDS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0f4571-e752-d925-e053-2995a90afd3a | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba48b351-0d7f-5a41-e053-2a95a90a348c | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED COCONUT AND WARM VANILLA HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0ffbf9-7dd0-f685-e053-2995a90a0be0 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba49e27b-1ade-a75a-e053-2a95a90a1843 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba4979a3-ae30-42e4-e053-2995a90abfe7 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | SWEET TREATS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0fa3cb-8c25-7511-e053-2995a90a4287 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED LAVENDER AND HYSSOP HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba484531-ef7b-17ed-e053-2995a90a50b3 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba4a573d-def4-a735-e053-2995a90a4f29 | 2024-11-07 | Warnings | M016 |
| Dove | HAND SANITIZER LAVENDER | Conopco Inc. d/b/a/ Unilever | ddcb0871-9903-125f-e053-2a95a90a75de | 2024-11-07 | Warnings | M016 |
| Dove | MOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT | Conopco Inc. d/b/a/ Unilever | debc5983-e8bc-c6d5-e053-2995a90af774 | 2024-11-07 | Warnings | M016 |
| Baby Dove | 8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREE | Conopco Inc. d/b/a/ Unilever | df734b51-33ae-d6b7-e053-2995a90a08cc | 2024-11-07 | Warnings | M016 |
| Dove | HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT | Conopco Inc. d/b/a/ Unilever | df73e518-caec-a73b-e053-2995a90a69f5 | 2024-11-07 | Warnings | M016 |
| Dove | HAND SANITIZER DEEP MOISTURE | Conopco Inc. d/b/a/ Unilever | ddca7c55-0a7e-cea6-e053-2995a90ace5a | 2024-11-07 | Warnings | M016 |
| Dove | HAND SANITIZER SHEA BUTTER | Conopco Inc. d/b/a/ Unilever | ddcad36b-1909-3bbb-e053-2995a90a295a | 2024-11-07 | Warnings | M016 |
| Dove | NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION | Conopco Inc. d/b/a/ Unilever | ddcbab1c-7af9-2656-e053-2995a90ad07a | 2024-11-07 | Warnings | M016 |
| Dove | HAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENT | Conopco Inc. d/b/a/ Unilever | df74d901-c86c-ed71-e053-2995a90a39c2 | 2024-11-07 | Warnings | M016 |
| Aveeno Baby Calming Comfort Bath Plus Set | DIMETHICONE | Kenvue Brands LLC | 2c44fbc7-588f-41e2-953c-eebf24eecbf9 | 2024-11-06 | Warnings | M016 |
| Aveeno Baby Welcome Little One Gift Basket | DIMETHICONE | Kenvue Brands LLC | e05e3c63-1691-7a86-e053-2a95a90a6bcb | 2024-11-06 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0395-0413-96 | 00395041396 | 177 mL in 1 BOTTLE, PLASTIC (0395-0413-96) | 177 ml | 2017-11-13 | 0000-00-00 | No | No | Current |