NDC 55553-474 - ACL20S SINGLE SHOT EPIDURAL

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: 55553-474
Package NDCs from labels: 55553-474-02
Manufacturer: Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date: 2013-02-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ACL20S SINGLE SHOT EPIDURAL	Clint Pharmaceuticals, Inc. \| Smiths Medical ASD, Inc. \| Hospira, Inc. \| Aplicare, Inc. \| Kwang Myung Pharm. Co., Ltd.	2013-02-12	MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-4713-65	ACL20S SINGLE SHOT EPIDURAL	5 mL in 1 AMPULE	INJECTION, SOLUTION	5 mL	10 mg in 1mL	2
55553-474-02	ACL20S SINGLE SHOT EPIDURAL	1 in 1 PACKAGE, COMBINATION	KIT	1		2
55553-474-02	ACL20S SINGLE SHOT EPIDURAL	30 in 1 CASE	KIT	30		2
65282-1510-1	ACL20S SINGLE SHOT EPIDURAL	10 mL in 1 AMPULE	SOLUTION	10 mL	9 mg in 1mL	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55553-474	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2	4 package rows	20130220_a8238514-87db-47b2-98e7-32f3e0c19ba5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
IODINE	ACTIVE MOIETY	9679TC07X4	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Lidocaine	ACTIVE MOIETY	98PI200987	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]	2

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 72 of 74 · 1,471 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUNA FLAM RELIEF	ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -	Guna spa	af5a9c74-e1c7-6574-e053-2995a90a3d10	2020-09-15	Warnings	Exact identifier unii: 2968PHW8QP
SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ac0fd44a-3f39-8d7e-e053-2995a90afeec	2020-08-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Cardioplegic	CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Corporation	1fd50ce5-2799-4c26-81da-02cf0578dd9e	2020-06-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a62b71db-8ba2-6f6b-e053-2a95a90a29d1	2020-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
LACTATED RINGERS AND DEXTROSE	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	a62cf623-9b8a-37e0-e053-2995a90add5b	2020-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Hay Fever	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS	Newton Laboratories, Inc.	a6045b91-d361-2731-e053-2a95a90a9772	2020-05-18	Warnings	Exact identifier unii: 451W47IQ8X
Isolyte S	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	B. Braun Medical Inc.	7e8fe27f-ff82-48c1-9bf6-3c589c8e985d	2020-05-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
DEXTROSE AND SODIUM CHLORIDE	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93	2020-04-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	b8803e38-fe30-48ec-9399-013f2880e0eb	2020-04-09	Warnings, Adverse reactions	Exact identifier rxcui: 1737566
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2b8220f-e33a-51c3-e053-2995a90a0734	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2bba76a-08ce-6902-e053-2995a90ab9c9	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Electrolyte No. 48	SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	b283a454-0c20-4fbf-92d3-dae1f3cd3cad	2020-02-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	fbc01464-8885-4075-af41-911ffec5ae92	2020-01-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Plasma-Lyte A	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	6ec9e61c-2c26-402f-8604-f446b2e34058	2019-08-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Company	becc7410-0a25-49f5-b0c3-240078479dc8	2019-01-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Skin Klear Acne Relief	TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR	Homeocare Laboratories	65afbc20-611b-4bc4-a151-c633bec66a82	2018-12-31	Warnings	Exact identifier unii: 451W47IQ8X
FREDS SALINE TWIN PACK LAXATIVE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	FRED'S	7d15057f-eb3b-477f-ab14-68c3c38ea910	2018-12-26	Warnings	Exact identifier unii: GR686LBA74

Reported adverse events (FAERS/openFDA)#

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