NDC 0168-0357-05 - Lidocaine and Prilocaine
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0168-0357
- Requested NDC
- 0168-0357-05
- Package NDCs from labels
- 0168-0357-05, 0168-0357-55, 0168-0357-56, 0168-0357-30
- Manufacturer
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Effective date
- 2026-10-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| lidocaine - E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 2026-10-15 | HUMAN PRESCRIPTION DRUG LABEL |
| LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5% | Preferred Pharmaceuticals Inc. | 2026-05-21 | HUMAN PRESCRIPTION DRUG LABEL |
| LIVIXIL PAK - Alvix Laboratories, LLC | Alvix Laboratories, LLC | 2019-05-28 | HUMAN PRESCRIPTION DRUG LABEL |
| PainGo KFT - International Brand Management, LLC | International Brand Management, LLC | 2017-03-08 | HUMAN PRESCRIPTION DRUG LABEL |
| General Surgery Kit | Centurion Medical Products | E. Fougera & Co. | 2013-10-02 | MEDICAL DEVICE |
| LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5% | Physicians Total Care, Inc. | 2010-10-01 | HUMAN PRESCRIPTION DRUG LABEL |
| Lidocaine and Prilocaine - Rebel Distributors Corp | Rebel Distributors Corp | 2010-10-01 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0168-0357-05 | Lidocaine and Prilocaine | 5 g in 1 TUBE | CREAM | 5 | 21 | |
| 0168-0357-30 | Lidocaine and Prilocaine | 30 g in 1 TUBE | CREAM | 30 | 21 | |
| 0168-0357-30 | Lidocaine and Prilocaine | 1 in 1 CARTON | CREAM | 1 | 21 | |
| 0168-0357-55 | Lidocaine and Prilocaine | 1 in 1 CARTON | CREAM | 1 | 21 | |
| 0168-0357-56 | Lidocaine and Prilocaine | 1 in 1 CARTON | CREAM | 1 | 21 | |
| 0168-0357-30 | PainGo KFT | 30 g in 1 TUBE | CREAM | 30 g | 25 mg in 1g | 13 |
| 0168-0357-55 | General Surgery Tray | 5 g in 1 TUBE | CREAM | 5 g | 25 mg in 1g | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0168-0357 | LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 19 | Current NDC, Legacy NDC, 5 package rows | 20241009_833cd52c-6470-49c4-937f-1393971f4db9.zip |
| 0168-0357 | PAINGO KFT (PRILOCAINE, LIDOCAINE, METHYL SALICYLATE, MENTHOL) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC] | 13 | Current NDC, Legacy NDC | 20170308_cd9ca2e8-14fb-4d1e-bb31-7f354666e563.zip |
| 0168-0357 | GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS] | 1 | Current NDC, Legacy NDC | 20131112_88c0ffed-a553-444e-9800-6c8c80df7690.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0357-30 | GM - Gram | 0168-0357 | 5044f417-d8a0-4b92-96d6-a36f07f67c5b | 1 | 2012-07-24 |
| 0168-0357-55 | GM - Gram | 0168-0357 | 8471d1ad-8232-4e9d-8410-f66313faba05 | 1 | 2012-07-24 |
| 0168-0357-56 | EA - Each | 0168-0357 | 0dc71ab3-ee35-4018-87e6-891c0ebe73aa | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Lidothol | LIDOCAINE HCL, MENTHOL | Asclemed USA, Inc. | 6d7adaca-67dd-4a4b-a85c-d1c2a568dee2 | 2022-09-09 | Warnings, Adverse reactions | L7T10EIP3A |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80 | Allergan, Inc. | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 2022-09-01 | Warnings | PDC6A3C0OX |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Alexso, Inc | 5dbd5fc0-a27e-4979-aca7-28f73096fd5f | 2022-08-18 | Warnings | L7T10EIP3A LAV5U5022Y |
| Glycerinum | GLYCERINUM | Hahnemann Laboratories, INC. | e34f8796-85b5-2946-e053-2995a90a251e | 2022-07-08 | PDC6A3C0OX | |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | PDC6A3C0OX |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Addiclenz | BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | e39235ea-2a2f-44a7-92d6-fb1d428ebabd | 2022-05-12 | Warnings | OJ245FE5EU |
| Blockaid | LIDOCAINE, TETRACAINE | SofTap Inc | de3af3fa-8acf-2379-e053-2995a90ac77d | 2022-05-06 | Warnings | 98PI200987 |
| Minnerva II | LIDOCAINE, EPINEPHRINE | SofTap Inc | ddd34237-7770-19b3-e053-2995a90af775 | 2022-05-05 | Warnings | 98PI200987 |
| lidocaine | LIDOCAINE | Proficient Rx LP | f9b290d2-0e24-4ca8-bca2-3016f5c404df | 2022-05-01 | Warnings, Adverse reactions | 98PI200987 |
| Lidocaine | LIDOCAINE | Actavis Pharma, Inc. | 4d04052c-3e0a-469a-9265-99604f13e507 | 2022-04-30 | Warnings, Adverse reactions | 98PI200987 |
| Lidocaine | LIDOCAINE | Proficient Rx LP | 2c396307-cf12-41d0-89e6-0f4ec74df55e | 2022-04-01 | Warnings, Adverse reactions | 98PI200987 |
| Miracle FootCream Lavender | UREA, GLYCERIN, ALOE, DISODIUM EDTA | Aloe Vera Korea Co.,Ltd. | db520c80-2a2a-5eb1-e053-2995a90a5bb4 | 2022-03-28 | Warnings | PDC6A3C0OX ZY81Z83H0X |
| Miracle FootCream Lemon | UREA, GLYCERIN, ALOE, DISODIUM EDTA | Aloe Vera Korea Co.,Ltd. | db525c63-29fd-2033-e053-2995a90a56b9 | 2022-03-28 | Warnings | PDC6A3C0OX ZY81Z83H0X |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Aewajin HasuoShampoo | MENTHOL, SALICYLIC ACID, PANTHENOL | MISOCOS | d4950ac9-8c05-989a-e053-2995a90ac6b7 | 2022-01-02 | Warnings | L7T10EIP3A |
| OHM Muscle and Joint Pain Relief | ARNICA, ACONITUM NAP, ARNICA, BELLADONNA, BELLIS, CALC FLUOR, CALC PHOS, CALENDULA, ECHINACEA, HAMAMELIS, HYPERICUM, KALI MUR, LEDUM, MAG PHOS, RHUS TOX, RUTA, SYMPHYTUM. | OHM PHARMA INC. | c64eb2c5-fdde-4d68-bd5f-d892c64b0f5c | 2021-12-29 | Warnings | OZ0E5Y15PZ |
| Treprostinil | TREPROSTINIL | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.