FDA.reportPublic FDA data

NDC 0517-1071 - Epinephrine

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
0517-1071
Package NDCs from labels
0517-1071-25
Manufacturer
American Regent, Inc.
Effective date
2011-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EPINEPHRINE INJECTION, USPAmerican Regent, Inc.2011-08-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-1071-25ML - Milliliter0517-107196b8474d-85e8-483c-8b9d-5e4dc77a1cc012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHEPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BHEPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0REPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1

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 17 of 63 · 1,242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
unii: 451W47IQ8X
ActivMendARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS, NATRUM MURATICUMCearna, Inc.baefc5d4-a7e4-4ba2-e053-2995a90a4b862025-12-23WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough DaytimeCALCIUM SULFIDE,GOLDENSEAL,ONION,PHOSPHORUS,PULSATILLA VULGARIS, SODIUM CHLORIDEHyland's Consumer Health Inc.e6118c79-b6d5-5c09-e053-2a95a90a30cf2025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough DaytimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.804e0e7a-20eb-128b-e053-2991aa0aa82c2025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: 451W47IQ8X
Hair and Nail TonicAVENA, DNA, ELAEIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS, HEPAR SUIS, KALI SULPH, NAT MUR, NICOTINAMIDUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, THUJA OCC, THYROIDINUM, URTICA UR.Eight and Company L.L.C35bda785-b3a7-4928-aaea-27bf9fb6abb52025-12-18WarningsExact identifier
unii: 451W47IQ8X
epinephrineEPINEPHRINEGLENMARK PHARMACEUTICALS INC., USAcc4ebb51-6020-4339-a36a-ec2380b7d28e2025-12-18Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINEProPharma Distribution384445ac-0696-e367-e063-6394a90a019f2025-12-18Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AdrenalinEPINEPHRINEProPharma Distribution3eef2920-0129-6dc2-e063-6294a90ac22a2025-12-18Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution3f79fb8b-d0e8-db2a-e063-6394a90ac1362025-12-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEProPharma Distribution43048b6b-3c83-eef4-e063-6294a90a34cb2025-12-18Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Body BalanceARALIA QUIN, ARNICA, AVENA, CARDUUS MAR, ELAEIS, GLANDULA SUPRARENALIS SUIS, NAT MUR, PHOSPHORICUM AC, THUJA OCCEight and Company L.L.C876cc0cf-c7a7-4656-adf9-1eff9bb626872025-12-18WarningsExact identifier
unii: 451W47IQ8X
epinephrineEPINEPHRINEGLENMARK PHARMACEUTICALS INC., USA01fd19cd-190c-4989-b733-60ba959412972025-12-18Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
ADRENOPLEXCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS BOVINE, SPLEEN (SUIS), CARDUUS MARIANUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.3c53c23e-7654-4e46-acf1-edb0d605ff3b2025-12-18WarningsExact identifier
unii: 451W47IQ8X
VermasodeARTEMISIA VULGARIS, CHELIDONIUM MAJUS, GRANATUM, SPIGELIA ANTHELMIA, RATANHIA, ARSENICUM ALBUM, FERRUM METALLICUM, CALCAREA CARBONICA, CINA, GAERTNER BACILLUS, GRAPHITES, MERCURIUS DULCIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, VERMIN NOSODENatural Creations, Inc180b5641-5692-42d4-8472-fdadccebd7462025-12-18WarningsExact identifier
unii: 451W47IQ8X
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: 451W47IQ8X
Equate Yeast ReliefCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURWAL-MART STORES INCd96aa608-ed8a-36cd-e053-2a95a90ac2862025-12-17WarningsExact identifier
unii: 451W47IQ8X
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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