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 table
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 table
Package NDC	Product	Description	Form	Quantity	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 table
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.

Matched openFDA labels page 139 of 144 · 2,871 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c5f3f1bc-adca-495f-b1bc-51c91d42a480	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Uber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	64db3a1f-d6c7-4766-a52c-a4b0c39e2633	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Walnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	582a8244-dab8-4861-9115-2e895a586fb9	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Bronze	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	377405a6-b6c6-4afb-9270-73d933029054	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9f7c8d53-6549-4bac-bbae-a2b73fdf6b05	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	5a22b123-9077-4b8a-ac4c-1bdd475c6ac3	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Calico	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	4647828c-661d-4ebe-b27e-13d8b89647b8	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	c82f36da-16ce-45f4-9786-2026a359060a	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Wheat	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	3d86dca5-9e33-4284-a4c1-f5eed64b0620	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Willow	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	0489a046-2173-4137-abff-c6a7cdb5e8fd	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	c67b3a39-ef78-5e81-e053-2a95a90a4786	2021-07-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	58465981-e84c-4eaf-b7d5-fad1666f63fc	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Bamboo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	b2259b27-e1a5-482c-8916-356c1ee9774a	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Bronze	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	199dde64-1dd3-4eb6-baef-261c97162f79	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Creme	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	753c34f2-3cb8-4df7-9aeb-ea926fb0279a	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Dune	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	745dd675-86ee-4acc-8333-4870e0a57c75	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.