warnings
For external use only. Flammable. Keep away from children.
First Aid
- Product NDC
- 69103-3553
- 11-digit product format
- 691033553
- Labeler code
- 69103
- Product ID
- 69103-3553_82d0a229-1c96-43b2-9f8c-44af83fae748
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- benzalkonium chloride and lidocaine
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Provision Medical
- Application
- part333A
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2014-12-02
- Marketing end
- 0000-00-00
- Substance
- BENZALKONIUM CHLORIDE; LIDOCAINE
- Active strength
- 1 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 69103-3553 | I | Inactivated by FDA | 2026-07-31 | ||
| excluded package | package | 69103-3553 | 69103-3553-1 | I | Inactivated by FDA | 2026-07-31 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mist | ALCOHOL | Derma Glove | 4513f6b9-ceac-415d-a1af-1f7585c5989e | 2025-11-14 | Warnings | |
| Hand Recovery | ALCOHOL | Derma Glove | 90058ba8-e55d-4318-9fc5-8f0d25dfdd99 | 2025-11-14 | Warnings | |
| KONIX Alcohol Antiseptic Hand Rub | KONIX ALCOHOL ANTISEPTIC HAND RUB | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS | 17435b35-815b-4292-a809-e533ea137b80 | 2025-01-29 | Warnings | |
| Hand Recovery | ALCOHOL | Derma Glove | 074a760f-9031-40c1-9867-95ef0345418d | 2025-01-08 | Warnings | |
| Mist | ALCOHOL | Derma Glove | 2a0bcc4e-5114-4afc-91cb-cb4816a63db2 | 2024-10-09 | Warnings | |
| Hand | LOTION | Derma Glove | ba9611a3-e2a4-4835-9ffe-aafe85a7cb9c | 2024-10-09 | Warnings | |
| Hand Relief | LOTION | Derma Glove | 45d130c9-0835-45bb-b525-86a2119c87d1 | 2024-10-09 | Warnings | |
| Mist | ALCOHOL | Derma Glove | b5bfd7f0-0f96-459e-84d4-24b2081ae46f | 2024-10-09 | Warnings | |
| Hand Relief | LOTION | Derma Glove | e2f89d56-5624-4a94-8151-1edb508232ac | 2024-10-09 | Warnings | |
| Hand Recovery | ALCOHOL | Derma Glove | 06f74478-57aa-4b8d-b888-55e1ee4fbd45 | 2024-10-09 | Warnings | |
| Hand Relief | LOTION | Derma Glove | d3926f48-3a42-42df-a850-47b3914ba3b6 | 2024-10-09 | Warnings | |
| Mist | ALCOHOL | Derma Glove | 7c21ee1c-ce2a-464b-8269-cdb3e59db094 | 2024-10-09 | Warnings | |
| Hand | LOTION | Derma Glove | bcd71f37-63aa-4ad9-a9be-e5519c7e66e7 | 2024-10-09 | Warnings | |
| Hand Relief | LOTION | Derma Glove | ffdfb167-0efa-4cd8-afdf-e1ff69ee6252 | 2024-10-09 | Warnings | |
| Mist | ALCOHOL | Derma Glove | 11c2939c-e77a-48f6-949c-9d508714012b | 2024-10-09 | Warnings | |
| Hand Recovery | ALCOHOL | Derma Glove | e6cfe092-cb2c-441b-8897-98626c43bef8 | 2024-10-09 | Warnings | |
| Hand | LOTION | Derma Glove | 642cc56f-9f39-46be-bbd8-a2346a0efac4 | 2024-10-09 | Warnings | |
| Hand | LOTION | Derma Glove | 93736944-7535-4035-93aa-4771138af8e3 | 2024-10-09 | Warnings | |
| Hand Relief | LOTION | Derma Glove | 39867f66-b641-4060-881d-161c2591d19c | 2024-10-09 | Warnings | |
| Hand Relief | LOTION | Derma Glove | 767cc1f2-89a2-4d0b-ae49-ad7b9afca18b | 2024-10-09 | Warnings |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69103-3553-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-92e6-f424-e053-dadaa90a57ce | a29ed953-2584-48f9-a1a2-930157f0c60c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69103-3553-1 | First Aid | 0.9 g in 1 POUCH | CREAM | 0.9 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69103-3553 | FIRST AID (BENZALKONIUM CHLORIDE AND LIDOCAINE) CREAM [PROVISION MEDICAL] | 1 | Legacy NDC, 1 package rows | 20141205_a29ed953-2584-48f9-a1a2-930157f0c60c.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 69103-3553-1 | 69103355301 | 0.9 g in 1 POUCH | 0.9 g | Historical |