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 |
|---|---|---|---|---|---|---|
| SEYTU Facial Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Omnilife USA, Inc. | 96fd37fb-c3ff-413f-b2c8-50754f320ecc | 2026-02-05 | Warnings | 15FIX9V2JP |
| No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Bamboo | OCTINOXATE, TITANIUM DIOXIDE | BCM Cosmetique SAS | ebfe03e7-614f-44b1-b1f1-78edc7e274cc | 2026-02-05 | Warnings | 15FIX9V2JP |
| DPT-TOX | DROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJA | Nutrition Center Inc dba Nutri-West dba Micro-West | 5e39f4e6-939f-4b71-9cc5-6d4b8711ea32 | 2026-02-04 | Warnings | ETJ7Z6XBU4 |
| SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42 | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 86630e82-f249-4866-82dd-3e21feb266c4 | 2026-02-04 | Warnings | 15FIX9V2JP |
| Meteoric Iron Prunus | METEORIC IRON PRUNUS | Uriel Pharmacy Inc. | e9020757-2393-4a22-9665-25da0a0993d0 | 2026-02-03 | Warnings | ETJ7Z6XBU4 |
| Mold, Yeast and Dust | ACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEA | NaturalCare | e0f53f47-acd9-43e2-a7a2-2a500bc9dc1b | 2026-02-03 | Warnings | ETJ7Z6XBU4 |
| Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN | HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE | Oracle Cosmetic Co., Ltd. | 21424f78-f8d5-6a9b-e063-6294a90ab7dc | 2026-02-02 | Warnings | 15FIX9V2JP |
| Reef safe unscented SPF 50 mineral sunscreen 01 | TITANIUM DIOXIDE, ZINC OXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 49a77ad4-508c-9617-e063-6394a90a5623 | 2026-01-30 | Warnings | 15FIX9V2JP |
| JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33 | TITANIUM DIOXIDE AND ZINC OXIDE | Cosmetic Solutions LLC | d65ae1c9-dff5-4612-b8be-fa59bba03b81 | 2026-01-30 | Warnings | 15FIX9V2JP |
| SHISEIDO SPORTS BB DARK | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | f4fc4b6a-9507-496e-9ecb-8400055ecf2d | 2026-01-28 | Warnings | 15FIX9V2JP |
| Hampton Sun SPF 30 Mineral | ZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00% | S&C Hampton Sun LLC | b8ee428e-07d3-4c6c-853c-cfbe3e4002d9 | 2026-01-28 | Warnings | 15FIX9V2JP |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI | LE COSMETICS INC | 4963658b-59bb-b313-e063-6394a90a0a51 | 2026-01-27 | Warnings | 15FIX9V2JP |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO | LE COSMETICS INC | 49644002-153f-c254-e063-6394a90a46eb | 2026-01-27 | Warnings | 15FIX9V2JP |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABO | LE COSMETICS INC | 49643a56-3627-67f8-e063-6294a90a2d7b | 2026-01-27 | Warnings | 15FIX9V2JP |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Caymans | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANS | LE COSMETICS INC | 49644002-153e-c254-e063-6394a90a46eb | 2026-01-27 | Warnings | 15FIX9V2JP |
| SURFERS BARRIER SPF 50 | ZINC OXIDE, TITANIUM DIOXIDE | Avasol LLC | ec55eef0-17e6-416d-bd5e-548f2f323cea | 2026-01-26 | Warnings | 15FIX9V2JP |
| ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA | TITANIUM DIOXIDE | LG Household and Healthcare, Inc. | 65e70306-9e79-494d-9217-a43002f16307 | 2026-01-23 | Warnings | 15FIX9V2JP |
| O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum | TITANIUM DIOXIDE | LG Household and Healthcare, Inc. | c15ffd23-271d-458d-9048-9bc50331d5d7 | 2026-01-23 | Warnings | 15FIX9V2JP |
| MISSHA GLOW WEIGHTLESS PRIMING SUNSCREEN | ZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE | Able C&C Co., Ltd. | 48f6361d-d738-62df-e063-6294a90aaac5 | 2026-01-22 | Warnings | 15FIX9V2JP |
| SOLBAR SUNSCREEN 40 SHIELD | SUNSCREEN | Person and Covey | 48fcd463-8ce4-1e78-e063-6394a90a98e7 | 2026-01-22 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.