NDC 69420-1001-01 - Cyclobenzaprine Hydrochloride
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
- 69420-1001
- Requested NDC
- 69420-1001-01
- Package NDCs from labels
- 69420-1001-3, 69420-1001-2, 69420-1001-1, 69420-1001-01
- Manufacturer
- SA3, LLC
- Effective date
- 2026-09-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Cyclobenzaprine Hydrochloride - SA3, LLC | SA3, LLC | 2026-09-28 | HUMAN PRESCRIPTION DRUG LABEL |
| CYCLOBENZAPRINE HYDROCHLORIDE - Direct_Rx | Direct_Rx | 2026-08-27 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine Hydrochloride - Proficient Rx LP | Proficient Rx LP | 2026-05-01 | HUMAN PRESCRIPTION DRUG LABEL |
| CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only | Preferred Pharmaceuticals, Inc. | 2026-04-01 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine HCL - PHOENIX RX LLC | PHOENIX RX LLC | 2026-01-16 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine Hydrochloride - A-S Medication Solutions | A-S Medication Solutions | 2025-12-04 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine HCL - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine Hydrochloride - Quality Care Products LLC | Quality Care Products LLC | 2024-12-17 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine Hydrochloride - Bryant Ranch Prepack | Bryant Ranch Prepack | 2024-08-20 | HUMAN PRESCRIPTION DRUG LABEL |
| STARCH, CORN - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2024-05-07 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine Hydrochloride - Unit Dose Services | Unit Dose Services | 2021-10-22 | HUMAN PRESCRIPTION DRUG LABEL |
| CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only | NuCare Pharmaceuticals, Inc. | 2021-02-23 | HUMAN PRESCRIPTION DRUG LABEL |
| NOpioid-LMC - Skya Health, LLC | Skya Health, LLC | 2020-10-08 | HUMAN PRESCRIPTION DRUG LABEL |
| NOpioid-LMC - Skya Health, LLC | Skya Health, LLC | 2020-10-01 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine Hydrochloride - Aidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals LLC | 2015-12-10 | HUMAN PRESCRIPTION DRUG LABEL |
| CYCLOBENZAPRINE HYDROCHLORIDE - DIRECT RX | DIRECT RX | 2015-08-10 | HUMAN PRESCRIPTION DRUG LABEL |
| Cyclobenzaprine Hydrochloride - All Pharma, LLC | All Pharma, LLC | 2015-03-26 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69420-1001-1 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 8 | |
| 69420-1001-2 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 8 | |
| 69420-1001-3 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69420-1001 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20220219_a4ae481f-9e47-470a-b4d1-5a33c0df8761.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69420-1001-1 | EA - Each | 69420-1001 | e6ea69a7-5e27-4f6a-a746-14512576dd48 | 1 | 2015-05-05 |
| 69420-1001-2 | EA - Each | 69420-1001 | 2f4ecc40-7956-4cca-9600-72c4ab2186b4 | 1 | 2020-02-13 |
| 69420-1001-3 | EA - Each | 69420-1001 | ba51461b-7957-4db7-8540-c071baa5269f | 1 | 2020-02-13 |
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 |
|---|---|---|---|---|---|---|
| FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS | POVIDONE, POLYVINYL ALCOHOL SOLUTION | Harrow Eye, LLC | 049e9cc9-0663-53bc-e063-6294a90a2c4f | 2026-09-04 | Warnings | 532B59J990 |
| Hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | CVS Pharmacy | 3167c918-a7d3-46a1-a85b-64f9c22916f2 | 2026-09-04 | Warnings | PDC6A3C0OX |
| Equate Menthol Pain Relieving | MENTHOL | Wal-Mart Stores Inc | d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc | 2026-09-03 | Warnings | L7T10EIP3A |
| ZHI Technologies | LIDOCAINE, MENTHOL | ZHI Technologies, Inc. | 6717e995-4d2d-49e8-8ecf-7c62557dfdef | 2026-09-03 | Warnings | 98PI200987 L7T10EIP3A |
| Komxsum LIDOCAINE Cream | LIDOCAINE 4% CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5a9feae0-9be4-e736-e063-6294a90abe55 | 2026-09-03 | Warnings | 98PI200987 |
| FREEZE EASE Roll-On | MENTHOL | Global America Group LLC | 1869cc0d-a056-45de-aede-23b09b61ed12 | 2026-09-02 | Warnings | L7T10EIP3A |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | 37056cab-953e-43ba-9b4c-163a739a52f7 | 2026-09-02 | Warnings, Adverse reactions | 828299 0VE05JYS2P |
| Gaimoa Lidocaine Pain Relief Gel Patches | LIDOCAINE PAIN RELIEF GEL PATCHES | Henan Enokon Medical Instrument Co., Ltd. | 5a68fe67-5c15-af9a-e063-6294a90a7ec1 | 2026-09-01 | Warnings | 98PI200987 L7T10EIP3A |
| Ramedica Herbal Wonder Balm | CAMPHOR, MENTHOL | Ramedicare Sdn. Bhd. | cfb2ea0e-a1f6-4fdf-b866-346bbe78788f | 2026-09-01 | Warnings | L7T10EIP3A |
| La Vaquita New Regular | METHYL SALICYLATE | Delon Laboratories (1990) Ltd | d62186ac-afbb-443e-98c2-f0d122422a3c | 2026-09-01 | Warnings | L7T10EIP3A |
| ActivICE | MENTHOL | Medline Industries, LP | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 2026-09-01 | Warnings | L7T10EIP3A |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | 30e61110-5bc8-4134-8456-538558479735 | 2026-09-01 | Warnings, Adverse reactions | 0VE05JYS2P |
| La Vaquita New Extra | METHYL SALICYLATE, MENTHOL | Delon Laboratories (1990) Ltd | 3097a01b-cee5-492f-b65a-63992fb28e3a | 2026-09-01 | Warnings | L7T10EIP3A |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE | HEXYLRESORCINOL AND MENTHOL | Reckitt Benckiser LLC | 4a938e15-a996-8538-e063-6294a90ad4ee | 2026-09-01 | Warnings | L7T10EIP3A |
| Lidocaine Cream | LIDOCAINE | InvaDerm Corporation | 5a7273d1-1dbc-420e-e063-6294a90a8629 | 2026-09-01 | Warnings | 98PI200987 |
| Lidocaine Phenylephrine | LIDOCAINE PHENYLEPHRINE | YYBA CORP | 5a72a190-2129-411e-e063-6394a90a08c2 | 2026-09-01 | Warnings | 98PI200987 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | ceb125d9-8c1b-498c-b0f0-f18756ede442 | 2026-09-01 | Warnings | L7T10EIP3A |
| Orajel 4X Medicated Toothache and Gum Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1c82b4-02b3-d456-e063-6294a90a16bb | 2026-08-31 | Warnings | L7T10EIP3A |
| Orajel 4X Medicated Toothache and Gum PM Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1cdaf4-3388-280c-e063-6294a90ac70f | 2026-08-31 | Warnings | L7T10EIP3A |
| REINREUDE SMELLING SALTS | MENTHOL 15% SMELLING SALTS | Hubei Minxin Pharmaceutical Co., Ltd. | 5a539219-f9b8-5e94-e063-6294a90a2593 | 2026-08-31 | Warnings | L7T10EIP3A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.