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 |
|---|---|---|---|---|---|---|
| Sciatica Relief | ARNICA MONTANA FLOWER, BRYONIA ALBA WHOLE, MATRICARIA RECUTITA, PSEUDOGNAPHALIUM LUTEOALBUM LEAF, KALMIA LATIFOLIA LEAF, TOXICODENDRON PUBESCENS LEAF, VISCUM ALBUM LEAF | Homeocare Laboratories | 5fbffd54-0007-4b9b-922f-1c0e450abd55 | 2018-12-31 | Warnings | OZ0E5Y15PZ |
| MEDICATED LIP BALM | MENTHOL AND EUCALYPTUS | Burt's Bees, Inc. | 30da3cc5-6140-2dee-e054-00144ff8d46c | 2018-12-21 | Warnings | L7T10EIP3A |
| Instaflex Pain Relief Cream | MENTHOL | Adaptive Health, LLC | 911f5021-a851-444e-8c2a-2be4fa94e828 | 2018-12-21 | Warnings | L7T10EIP3A |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
| Cadira Compliant Blood Stat | LIDOCAINE / PRILOCAINE | Asclemed USA, Inc. | 79a31029-c221-4a4c-8dd9-bf78cbf2a16a | 2018-11-01 | Warnings, Adverse reactions | 197877 98PI200987 046O35D44R |
| LIDO BDK | LIDOCAINE, PRILOCAINE | Asclemed USA, Inc. | 51fd0589-e551-4583-98e1-1e8db19d7e6d | 2018-11-01 | Warnings, Adverse reactions | 98PI200987 046O35D44R |
| Lidocaine | LIDOCAINE | Amneal Pharmaceuticals LLC | d1509740-f9f1-44e3-8fde-51d8683fcd87 | 2018-10-28 | Warnings, Adverse reactions | 98PI200987 |
| Fast Freeze | CAMPHOR (NATURAL), MENTHOL | Natural Essentials Inc. | 60c94da8-6c00-4544-a9a6-a3e87ebabd68 | 2018-10-18 | Warnings | L7T10EIP3A |
| Analgesic | MENTHOL | Safetec of America, Inc. | a90266d4-1e71-4805-aeca-6f8ed45135bb | 2018-10-01 | Warnings | L7T10EIP3A |
| COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF | MENTHOL | NATURAL ESSENTIALS, INC. | 9fcc79e6-8176-4ebc-8602-0649b02fab86 | 2018-09-27 | Warnings | L7T10EIP3A |
| Bio Rock Water | ROCK WATER | BioActive Nutritional, Inc. | 178bd16d-0d4f-49d8-866b-8ab3a3c6889d | 2018-07-30 | Warnings | 059QF0KO0R |
| Additox | TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | BioActive Nutritional, Inc. | 319ee2fe-58e3-495e-bf0d-df201f6fbb1c | 2018-07-18 | Warnings | OJ245FE5EU |
| Pure-Aid | CAMPHOR, MENTHOL, METHYL SALICYLATE | Kareway Product, Inc. | 6def9da7-e118-fd5c-e053-2991aa0a65d2 | 2018-06-05 | Warnings | L7T10EIP3A LAV5U5022Y |
| Soundbody | LIDOCAINE, MENTHOL | Kareway Product, Inc. | 6c83ec36-3e3d-07a9-e053-2a91aa0ac54c | 2018-05-18 | Warnings | 98PI200987 L7T10EIP3A |
| Avedana Cool Hot Ice | MENTHOL | Unipack, Inc. | 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3 | 2018-05-01 | Warnings | L7T10EIP3A |
| SunBurnt Advanced After-Sun | CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, CANTHARIS VESICATORIA | Welmedix LLC | dcb2fd62-df8e-4a26-b7ed-274caefeeb76 | 2018-03-20 | Warnings | P0M7O4Y7YD |
| Pure-Aid | LIDOCAINE, MENTHOL | Kareway Product, Inc. | 6679cada-f083-26e8-e053-2a91aa0adcc5 | 2018-03-02 | Warnings | 98PI200987 L7T10EIP3A |
| Ivy-Dry Super | BENZYL ALCOHOL, CAMPHOR, MENTHOL | Ivy-Dry, Inc. | 4792a667-2378-4b3d-968d-9efb1866792f | 2017-12-27 | Warnings | L7T10EIP3A |
| Pain Relief | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCH | Kareway Product, Inc. | d3ede306-9ef7-4a89-896b-c083f6e43c85 | 2017-12-05 | Warnings | LAV5U5022Y |
| ICY FREEZE | MENTHOL | NATURAL ESSENTIALS, INC. | 41b2e9a0-818d-4188-8c9d-8ff7c0d0519b | 2017-12-01 | Warnings | L7T10EIP3A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.