diphenhydramine hcl and zinc acetate
- Product NDC
- 45802-358
- 11-digit product format
- 458020358
- Labeler code
- 45802
- Product ID
- 45802-358_888ad1f9-aeb1-4778-8d5a-734e734036e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride, Zinc Acetate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-12-05
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
- Active strength
- 2; .1 g/100g; g/100g
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- 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
- diphenhydramine hcl and zinc acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 2 g/100g |
| ZINC ACETATE | .1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
| FM5526K07A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1087026 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6d7a7615-9ae7-4c55-8a84-dba746f535d7 | Available on FDA.report |
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 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 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 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45802-358-03 | diphenhydramine hcl and zinc acetate | 1 in 1 CARTON | CREAM | 1 | 7 | |
| 45802-358-03 | diphenhydramine hcl and zinc acetate | 28 g in 1 TUBE | CREAM | 28 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-358-03 | GM - Gram | 45802-358 | 5ee96519-a817-4023-a42d-f209f5a5fe72 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 45802-358 | DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240830_6d7a7615-9ae7-4c55-8a84-dba746f535d7.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 |
|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | Encube Ethicals, Inc. | 969cd576-82d3-4662-bbc1-3587a1f6a564 | 2025-11-10 | Warnings | M017 |
| Jelcaine Sterile | LIDOCAINE HCL JELLY USP, 2% | Brookfield Pharmaceuticals, LLC | 1a39d1de-7aa2-3068-e063-6394a90aed85 | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | c6e86a0f-6f9b-45b7-86ce-0bb1c198061a | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | 97ae1993-7268-4b7f-92e2-6004337d5650 | 2025-11-10 | Warnings | M017 |
| MENTHOL AND METHYL SALICYLATE | ELECTRIC MEDICATED BALM ULTRA STRENGTH | FEI FAH MEDICAL MANUFACTURING PTE LTD | 91e6d3b9-25bb-4015-9d96-bd27f93e5ada | 2025-11-10 | Warnings | M017 |
| E MEI SHAN MEDICATED | CAMPHOR, MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | bda1e7c1-42df-4126-a512-80f843b07fd0 | 2025-11-10 | Warnings | M017 |
| EXTRA STRENGTH HUA TUO PAIN RELIEVING | CAMPHOR AND MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | 9850754b-ac94-4ec6-b75a-8096e5ac9456 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| TONG FENG DING PAIN RELIEF | CAMPHOR AND MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 5ef90782-8201-47d1-b57f-f032d4c9b06a | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 1388ab3a-c26f-427d-898d-0d88411a5fba | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Capsaicin Patch Hot | CAPSAICIN | MADISON ONE ACME INC | f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Lung Choy Shung Pain Relief Liquid | MENTHOL AND CAMPHOR | MADISON ONE ACME INC | 4842c6ec-7823-4f6b-afc4-258fce2c2391 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| 701 DIEDA ZHENGTONG YAOGAO MEDICATED | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | 115041ff-5046-4ca4-b54b-5652037e74bd | 2025-11-10 | Warnings, Adverse reactions | M017 |
| EXTRA STRENGTH HUA TUO PAIN RELIEF | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | 0f269a41-4b56-4e22-b9cb-17d99bf76a57 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| ZANG HONG HUA PAIN RELIEVING | CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE | MADISON ONE ACME INC | e0a8811c-07cf-4dee-a0e5-13b8af1b27b6 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| NECK AND LUMBAR PAIN RELIEVING BALM | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | d06f0650-a5f6-4bc1-a70b-b0fc16968fa9 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| SHU JIN HUO LUO PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | ccb6740d-3399-4a2b-ae65-15ca557ba83b | 2025-11-10 | Warnings, Adverse reactions | M017 |
| GuruNanda Pain Relief | LIDOCAINE HYDROCHLORIDE | GuruNanda, LLC. | 3ab6a133-8dca-e14e-e063-6394a90a85e7 | 2025-11-10 | Warnings | M017 |
| HUO LUO PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 65581716-5a2c-4ee8-816d-00caed7b95b4 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| JOSEPHS LION PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e | 2025-11-10 | Warnings, Adverse reactions | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1087026 | diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream | PSN | 6d7a7615-9ae7-4c55-8a84-dba746f535d7 | 7 |
| 1087026 | diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream | SCD | 6d7a7615-9ae7-4c55-8a84-dba746f535d7 | 7 |
| 1087026 | diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream | SY | 6d7a7615-9ae7-4c55-8a84-dba746f535d7 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45802-358-03 | 45802035803 | 1 TUBE in 1 CARTON (45802-358-03) / 28 g in 1 TUBE | 1 tube | 2005-12-05 | 0000-00-00 | No | No | Current |