NDC 68071-3475-01 - 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
- 68071-3475
- Requested NDC
- 68071-3475-01
- Package NDCs from labels
- 68071-3475-2, 68071-3475-3, 68071-3475-1, 68071-3475-4, 68071-3475-9, 68071-3475-01
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2025-01-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Cyclobenzaprine hydrochloride, USP | NuCare Pharmaceuticals,Inc. | 2025-01-14 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3475-1 | CYCLOBENZAPRINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 5 | |
| 68071-3475-2 | CYCLOBENZAPRINE HYDROCHLORIDE | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | 5 | |
| 68071-3475-3 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 | |
| 68071-3475-4 | CYCLOBENZAPRINE HYDROCHLORIDE | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | 5 | |
| 68071-3475-9 | CYCLOBENZAPRINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3475 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, 5 package rows | 20250116_01e18825-1cf9-a98c-e063-6294a90ae0a4.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 |
|---|---|---|---|---|---|---|
| SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | Shiseido Americas Corporation | b93f10dc-193d-4cda-94b6-3f0e54d89f21 | 2026-02-23 | Warnings | 15FIX9V2JP |
| SHISEIDO ULTIMATE SUN PROTECTOR MINERAL | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 5e31eee8-6532-47ea-99fc-22418791804b | 2026-02-23 | Warnings | 15FIX9V2JP |
| Allergy Maximum Strength | URTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDE | Forces of Nature | 122ca23e-43f1-4e5c-afc2-1418b1717679 | 2026-02-20 | Warnings | ETJ7Z6XBU4 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b47e7cb-17d6-6a7c-e063-6294a90abbea | 2026-02-20 | Warnings | 15FIX9V2JP |
| Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 | TITANIUM DIOXIDE, ZINC OXIDE | ALLAY SKIN SOLUTIONS LLC | 425bf1d7-f2cf-4237-9047-dd53054acd1c | 2026-02-18 | Warnings | 15FIX9V2JP |
| Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN | TITANIUM DIOXIDE | S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE | dacff3dc-49d7-6416-e053-2a95a90a85c6 | 2026-02-18 | Warnings | 15FIX9V2JP |
| Mitochondria Pro | ARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM, | Energique, Inc. | 2f365207-b730-428d-9465-8853e86e79ff | 2026-02-18 | Warnings | ETJ7Z6XBU4 |
| BIO COM 25 ACIDITY | NAT PHOS, NAT SULPH, SILICEA | BM Private Limited | 3b3c3455-b321-071d-e063-6394a90a0160 | 2026-02-17 | Warnings | ETJ7Z6XBU4 |
| CINA | AMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEA | BM PRIVATE LIMITED | 3b3c0874-90b5-deda-e063-6394a90a7802 | 2026-02-15 | Warnings | ETJ7Z6XBU4 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 06da53af-5b46-4e32-a64c-9677e27ae229 | 2026-02-14 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Acne/Pimple Control | CALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDE | Forces of Nature | e871e46e-463e-49ec-a2af-5aa98548ee12 | 2026-02-13 | Warnings | ETJ7Z6XBU4 |
| Fuligo | CIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEA | BM Private Limited | 3b27225f-4587-d915-e063-6294a90a7225 | 2026-02-12 | Warnings | ETJ7Z6XBU4 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Sportpharm LLC | d4e0f532-887b-40bb-80d6-5c4e5b1d64bf | 2026-02-11 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Alumier Labs | a9c970c8-b6e3-b0a1-e053-2a95a90a89c7 | 2026-02-09 | Warnings | 15FIX9V2JP |
| Mold, Yeast and Dust | ADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEA | NaturalCare | 32afa0f0-bca5-4246-bc2e-decd757fcf9d | 2026-02-09 | Warnings | ETJ7Z6XBU4 |
| Hampton Sun SPF 50 Mineral | ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00% | S&C Hampton Sun LLC | d6c33436-042e-44e8-8b55-98be6e246879 | 2026-02-06 | Warnings | 15FIX9V2JP |
| SHISEIDO WASO COLOR-SMART DAY MOISTURIZER | OCTINOXATE, TITANIUM DIOXIDE | Shiseido Americas Corporation | f291f077-1c72-48fc-bb19-c20bdeaaa596 | 2026-02-06 | Warnings | 15FIX9V2JP |
| SHISEIDO WASO COLOR-SMART DAY MOISTURIZER | OCTINOXATE, TITANIUM DIOXIDE | Shiseido Americas Corporation | 54f63dd8-e77f-42e4-a6d3-61ab7beecf50 | 2026-02-06 | Warnings | 15FIX9V2JP |
| GoodSense Eye Drops Advanced Relief Moisturizer | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Sportpharm LLC | 8d58dcbb-72a0-41f0-9eeb-613072a6d7ae | 2026-02-06 | Warnings | B697894SGQ |
| SEYTU Body Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Omnilife USA, Inc. | c411e9a6-b2ea-446b-a886-b92c61736e6c | 2026-02-05 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.