DiphenhydrAMINE Hydrochloride Injection, USP

Manufacturer
Hospira, Inc.
Effective date
2019-11-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
20
Source
legacy-cache
Hydrated at
2026-08-01 23:58:14

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical. For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled,...

Dosage and administration

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Hospira LogoHospira Logo
Rx only

DESCRIPTION

DESCRIPTION SECTION

Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. It occurs as a white, crystalline powder, is freely soluble in water and alcohol and has a molecular weight of 291.82. The molecular formula is C17H21NO • HCl and the structural formula is as follows:

Structural Formula for Diphenhydramine Hydrochloride
Structural Formula for Diphenhydramine Hydrochloride

Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride per mL for intramuscular or intravenous use. The solution for parenteral use has been adjusted to a pH between 4 and 6.5 with either sodium hydroxide or hydrochloric acid.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

Diphenhydramine hydrochloride in the injectable form has a rapid onset of action. Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of Diphenhydramine Hydrochloride Injection is not available.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical.

Antihistaminic

SPL UNCLASSIFIED SECTION

For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.

Motion Sickness

SPL UNCLASSIFIED SECTION

For active treatment of motion sickness.

Antiparkinsonism

SPL UNCLASSIFIED SECTION

For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Use in Neonates or Premature Infants

SPL UNCLASSIFIED SECTION

This drug should not be used in neonates or premature infants.

Use in Nursing Mothers

SPL UNCLASSIFIED SECTION

Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Use as a Local Anesthetic

SPL UNCLASSIFIED SECTION

Because of the risk of local necrosis, this drug should not be used as a local anesthetic.

Antihistamines are also contraindicated in the following conditions

SPL UNCLASSIFIED SECTION

Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

WARNINGS

WARNINGS SECTION

Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.

Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine.

Use in Pediatric Patients

SPL UNCLASSIFIED SECTION

In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation.

Use in the Elderly (approximately 60 years or older)

SPL UNCLASSIFIED SECTION

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Diphenhydramine hydrochloride has an atropine-like action and, therefore, should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Use with caution in patients with lower respiratory disease including asthma.

Information for Patients

INFORMATION FOR PATIENTS SECTION

Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol.

Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Drug Interactions

DRUG INTERACTIONS SECTION

Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc).

MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.

Pregnancy

PREGNANCY SECTION

Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric Use

PEDIATRIC USE SECTION

Diphenhydramine should not be used in neonates and premature infants (see CONTRAINDICATIONS).

Diphenhydramine may diminish mental alertness, or in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death (see WARNINGS and OVERDOSAGE).

See also DOSAGE AND ADMINISTRATION section.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The most frequent adverse reactions are italicized:

General

Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose, and throat.

Cardiovascular System

Hypotension, headache, palpitations, tachycardia, extrasystoles.

Hematologic System

Hemolytic anemia, thrombocytopenia, agranulocytosis.

Nervous System

Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.

Gastrointestinal System

Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.

Genitourinary System

Urinary frequency, difficult urination, urinary retention, early menses.

Respiratory System

Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness.

OVERDOSAGE

OVERDOSAGE SECTION

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms; dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Pediatric Patients, Other Than Premature Infants and Neonates

SPL UNCLASSIFIED SECTION

5 mg/kg/24 hours or 150 mg/m2/24 hours. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.

Adults

SPL UNCLASSIFIED SECTION

10 mg to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly; 100 mg if required; maximum daily dosage is 400 mg.

HOW SUPPLIED

HOW SUPPLIED SECTION

Diphenhydramine Hydrochloride Injection, USP is available as:

Unit of SaleConcentration
NDC 0409-2290-31
Carton of 10
1 mL fill in 2 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System
50 mg/mL

Carpuject™ Single-dose cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included.

Instructions for Use of the Syringe Systems

Instructions for using the Carpuject™ Syringe are available with the reusable Carpuject™ Holder, List 2049-02.

Carpuject™ Single-dose cartridges are to be used ONLY with Carpuject™ Holders, List 2049-02.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from freezing and light. Retain in carton until time of use.

 

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                     Hospira LogoHospira Logo

LAB-1300-3.0

Revised 05/2019

PRINCIPAL DISPLAY PANEL - 1 mL Carpuject Cartridge Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 mL Single-use Carpuject™
Sterile Cartridge Unit with Luer Lock

DiphenhydrAMINE
HCl Injection, USP

50 mg/mL

For Intravenous or Intramuscular Use

Rx only

HIGH POTENCY
PROTECT FROM LIGHT

Hospira

NDC 0409-2290-03

RL–5589

PRINCIPAL DISPLAY PANEL - 1 mL Carpuject Cartridge Label
PRINCIPAL DISPLAY PANEL - 1 mL Carpuject Cartridge Label

PRINCIPAL DISPLAY PANEL - 1 mL Carpuject Cartridge Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 mL
Single-use

NDC 0409-2290-31
Rx only

10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

DiphenhydrAMINE
HCl Injection, USP

50 mg/mL

HIGH POTENCY

For Intravenous or
Intramuscular Use

Carpuject Cartridges are to be used
ONLY with Carpuject Holders.

Hospira

PRINCIPAL DISPLAY PANEL - 1 mL Carpuject Cartridge Carton
PRINCIPAL DISPLAY PANEL - 1 mL Carpuject Cartridge Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2290-03ML - Milliliter0409-22907883c166-5f53-4d39-a53e-73a05cfd727d12017-09-11
0409-2290-11ML - Milliliter0409-2290812fa907-7024-4aa4-83aa-91a07608d99d12022-06-06
0409-2290-31ML - Milliliter0409-2290e798365d-9ce4-48d3-9c12-c31706accf6d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD4014
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I14
WATERINACTIVE INGREDIENT059QF0KO0R14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0409-22900409-2290-03, 0409-2290-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 322 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / ORALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBGEL / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBCAPSULE / ORAL7 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / PARENTERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBCREAM / TOPICAL38 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSHAMPOO / TOPICAL104 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / AURICULAR (OTIC)0.37 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBAEROSOL, METERED / RESPIRATORY (INHALATION)0.7 %w/wExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION / ORAL100 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IELIXIR / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IDISC / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBGEL / TOPICAL10 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS4.17 mgExact identifier — unii candidate
148 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040140-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-2084e616aacf4f…
2026-08-18 06:07:402026-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-203f01610625f2…
2019-09-15 20:21 UTC2019-09A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A040140-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040140-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040140-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040140-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040140-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040140-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040140-001AP18869cabd3fbd…
2019-12-14 00:12 UTC2019-12A040140-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040140-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040140-001AP1ea99ee380514…

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
92df626a-3da2-47ed-8ea1-f69f07b662573cfa4719-e616-4aa7-d8a0-98df761771362020-11-17Warnings, Adverse reactionsExact identifier
spl set id: 3cfa4719-e616-4aa7-d8a0-98df76177136

Reported adverse events (FAERS/openFDA)#

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