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 |
|---|---|---|---|---|---|---|
| Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Acupac Packaging, Inc. | 4ef4d44e-3421-535f-e063-6294a90a2fea | 2026-04-08 | Warnings | 15FIX9V2JP |
| Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Acupac Packaging, Inc. | 4ef5baf7-00b1-97aa-e063-6294a90aab9c | 2026-04-08 | Warnings | 15FIX9V2JP |
| Neutrogena Mineral Ultra Sheer Face SPF 70 | TITANIUM DIOXIDE, ZINC OXIDE | Acupac Packaging, Inc. | 4ef5dcd4-b2d0-bcd1-e063-6294a90a871f | 2026-04-08 | Warnings | 15FIX9V2JP |
| Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Acupac Packaging, Inc. | 4ef6b5fb-5495-001c-e063-6394a90ab7b3 | 2026-04-08 | Warnings | 15FIX9V2JP |
| Nu Colour Bioadaptive BB Plus Foundation - Light Golden | TITANIUM DIOXIDE | NSE Products, Inc. | faae6f47-19f3-41cb-8e0d-388569b5c73d | 2026-04-07 | Warnings | 15FIX9V2JP |
| Ultra Sunscreen | OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE | Jiangsu Senwo Medical Technology Co., Ltd. | 4ed974b8-6c11-08e0-e063-6294a90a7713 | 2026-04-07 | Warnings | 15FIX9V2JP |
| Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Acupac Packaging, Inc | 4ee39bbf-b7d7-8f87-e063-6294a90a2539 | 2026-04-07 | Warnings | 15FIX9V2JP |
| H-Focus Formula | AGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUM | Healing Natural Oils LLC | 4ee42911-3064-7f55-e063-6294a90abcc7 | 2026-04-07 | Warnings | ETJ7Z6XBU4 |
| H-Mood Formula | AGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUM | Healing Natural Oils LLC | 4ee5c82e-9edf-c36e-e063-6394a90a237f | 2026-04-07 | Warnings | ETJ7Z6XBU4 |
| Nu Colour Bioadaptive BB plus Foundation - Beige | TITANIUM DIOXIDE | NSE Products, Inc. | f74e83fe-41a0-4998-ae53-30ed5af47592 | 2026-04-07 | Warnings | 15FIX9V2JP |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 2f89c8f6-7f3c-8396-e063-6294a90a643e | 2026-04-06 | Warnings, Adverse reactions | ANDA208170 828299 0VE05JYS2P |
| LensMate Preservative-Free Artificial Tears | LUBRICANT EYE DROPS | YD BIO USA, INC. | 4ebacb2b-9b2d-6bc1-e063-6294a90a3426 | 2026-04-05 | Warnings | 3NXW29V3WO |
| Exovisse Preservative-Free Artificial Tears | LUBRICANT EYE GEL DROPS | YD BIO USA, INC. | 4ebc154b-128b-9dde-e063-6294a90ae00e | 2026-04-05 | Warnings | 3NXW29V3WO |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Sportpharm LLC | 24653b10-bdf0-47c5-a1f4-dc25f3b86032 | 2026-04-03 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| EltaMD Skincare UV AOX Elements SPF50 Tinted | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 2c74209d-9b88-4c32-ad42-cd6de16c1fef | 2026-04-03 | Warnings | 15FIX9V2JP |
| EltaMD UV Restore Tinted | TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 4fc18856-01b3-43ed-9e1b-b4394e31aa3c | 2026-04-03 | Warnings | 15FIX9V2JP |
| Sunscreen for baby SPF50plus | OCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE | Guangzhou Senmai Biotechnology Co., Ltd. | 1cb7fbca-0874-ae53-e063-6294a90ab42a | 2026-04-02 | Warnings | 15FIX9V2JP |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7bdec2-abcc-0267-e063-6394a90ae47a | 2026-04-02 | Warnings | 15FIX9V2JP |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 17b47994-82d6-4f9d-8249-bdb55106c9b3 | 2026-04-02 | Warnings | 15FIX9V2JP |
| Sinus Defense | LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE | Micro Balance Health Products LLC | 9c2f51c5-aa41-414e-a966-32e02e9e79a2 | 2026-04-02 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.