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 70 of 74 · 1,471 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Fungisode	ARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHUR	Seroyal USA	55c5dfc4-3757-6ac2-e054-00144ff88e88	2021-07-22	Warnings	Exact identifier unii: QTT17582CB
0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c755e41b-acba-7234-e053-2995a90aff0f	2021-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Melange combination	CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA	Seroyal USA	0a071fbf-0075-4479-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 451W47IQ8X
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ed8fd0c1-ac42-4267-877e-ceadf3831c90	2021-04-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dr. Talbots Vital 12	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC	Talbot's Pharmaceuticals Family Products, LLC	c10bb804-8169-63da-e053-2a95a90a8306	2021-04-28	Warnings	Exact identifier unii: 451W47IQ8X
Dr. Talbots Infant Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC	c0963200-67dd-6349-e053-2a95a90adde1	2021-04-22	Warnings	Exact identifier unii: 451W47IQ8X
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	c3f8e83c-4fb9-91da-e053-2a95a90abd63	2021-04-12	Adverse reactions	Exact identifier unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live Better	SODIUM CHLORIDE	CVS Pharmacy	ccc3ab8c-b22f-420d-869b-f2a65b8c7180	2021-03-13	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	aeaed9cb-b629-4019-88d2-a916179427de	2021-02-19	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GUNA KIDNEY PLUS	CALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -	Guna spa	b8dacd94-8da1-4a8d-e053-2995a90acb67	2021-02-04	Warnings	Exact identifier unii: 451W47IQ8X
Natrum Muriaticum	NATRUM MURIATICUM	True Botanica, LLC	b30b2880-28a1-47bd-83e7-da885a7c6f77	2021-01-24	Warnings	Exact identifier unii: 451W47IQ8X
Met-Tox	ARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODES	wHITE mANUFACTURING INC DBA MICRO-WEST	e65db4c2-0bc7-4c50-8f18-b36ee004c4f5	2021-01-21	Warnings	Exact identifier unii: 451W47IQ8X
HPZ	ECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCC	White Manufacturing Inc. DBA Micro-West	dfbb5a35-8dfe-48f4-9177-6cb52fb44090	2021-01-21	Warnings	Exact identifier unii: 451W47IQ8X
Metal	ALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIA	NET Remedies	f7682a4e-c767-4429-98aa-e8c5ef6560a6	2021-01-19	Warnings	Exact identifier unii: 451W47IQ8X
3% Sodium Chloride	3% SODIUM CHLORIDE	Becton Dickinson and Company	a8058593-48af-457a-b0f0-166935c7d10c	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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