Diabetic Tussin Nighttime Cold and Flu

Manufacturer: Health Care Products | Hi-Tech Pharmacal Co., Inc.
Effective date: 2019-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:02:12

Label at a glance#

ProductDiabetic Tussin Nighttime Cold and Flu

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves common cold/flu symptoms including: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • muscular aches • fever • runny nose and sneezing

Dosage and administration

• take every 4 to 6 hours • do not exceed more than 5 doses in 24 hours for children under 12 years of age • do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age adults & children 12 years & over 10 mL (2 teaspoonfuls) children 6 years to under 12 years 5 mL (1 teaspoonful) children under 6 years ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-899-3116

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Diphenhydramine HCl 12.5 mg

Purposes

OTC - PURPOSE SECTION

Pain Relief

Cough Suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms including:

cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
muscular aches
fever
runny nose and sneezing

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adults take more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
with any other product containing diphenhydramine, even one used on the skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to enlargement of the prostate gland
cough that occurs with too much phlegm (mucus)
a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.

When using this product:

OTC - WHEN USING SECTION

you may get very drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in small children

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or swelling is present
fever gets worse or lasts more than 3 days
new symptoms occur
cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 to 6 hours
do not exceed more than 5 doses in 24 hours for children under 12 years of age
do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age

adults & children 12 years & over	10 mL (2 teaspoonfuls)
children 6 years to under 12 years	5 mL (1 teaspoonful)
children under 6 years	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
Store at room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame potassium, aspartame, citric acid, hypromellose, menthol, methylparaben, natural & artificial orange flavor, polyethylene glycol, potassium sorbate, propylene glycol, purified water. Sodium citrate may be used to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call: 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Rev. 452:04 12/11

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61787-452-04

Diabetic Tussin^®

DECONGESTANT FREE

Nighttime

Cold & Flu

FEVER, HEADACHE

BODY ACHES

COUGHS

SNEEZING

RUNNY NOSE

Liquid

Sodium

Sorbitol

Fructose

& Dyes

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

DIPHENHYDRAMINE HCl

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

4 FL OZ (118 mL)

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1094131	Acetaminophen/Dextromethorphan/diphenhydrAMINE (Oral Liquid)	acetaminophen 65 MG/ML / dextromethorphan hydrobromide 2 MG/ML / diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1094131	acetaminophen 325 MG / dextromethorphan HBr 10 MG / diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	3
1094131	acetaminophen 65 MG/ML / dextromethorphan hydrobromide 2 MG/ML / diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	3
1094131	APAP 325 MG / dextromethorphan hydrobromide 10 MG / diphenhydramine hydrochloride 12.5 MG per 5 ML Oral Solution	SY	3
1094131	APAP 65 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Diphenhydramine Hydrochloride 2.5 MG/ML Oral Solution	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61787-452-04	2021-01-29	C162847	48780-1	ba0f9c33-5d66-a910-e053-dadaa90a0b85	Drug Facts
61787-452-08	2021-01-29	C162847	48780-1	ba0f9c33-5d66-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61787-452-04	Diabetic Tussin Nighttime Cold and Flu	1 in 1 CARTON	LIQUID	1	3
61787-452-04	Diabetic Tussin Nighttime Cold and Flu	118 mL in 1 BOTTLE	LIQUID	118	3
61787-452-08	Diabetic Tussin Nighttime Cold and Flu	237 mL in 1 BOTTLE	LIQUID	237	3
61787-452-08	Diabetic Tussin Nighttime Cold and Flu	1 in 1 CARTON	LIQUID	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61787-452	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	3	Legacy NDC, 4 package rows	20191221_96ef6c88-ce06-4d7a-ab7b-42af64ba3149.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61787-452-08	ML - Milliliter	61787-452	e6bfcca0-539a-44b3-a276-31cb70817257	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	2
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Diabetic Tussin Nighttime Cold and Flu
Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl
WATER
ASPARTAME
ACESULFAME POTASSIUM
HYPROMELLOSE 2910 (4000 MPA.S)
POLYETHYLENE GLYCOL 400
POTASSIUM SORBATE
ANHYDROUS CITRIC ACID
PROPYLENE GLYCOL
METHYLPARABEN
MENTHOL, UNSPECIFIED FORM
TRISODIUM CITRATE DIHYDRATE
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61787-452	61787-452-04, 61787-452-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ASPARTAME	Z0H242BBR1	IACT
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

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 7 · 404 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / RECTAL		773 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		800 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CLOTH / TOPICAL	4.2 mg		Exact identifier — unii candidate 61 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, SOLUTION / INTRAMUSCULAR		1188 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION / SUBCUTANEOUS		75 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / SUBCUTANEOUS		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION / INTRAMUSCULAR		3480 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRACARDIAC		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, SUSPENSION / INTRAVITREAL	0.17 %w/v		Exact identifier — unii candidate 47 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET / ORAL		896 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	0.03 mg		Exact identifier — unii candidate 47 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	AEROSOL, FOAM / TOPICAL		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SYRUP / ORAL	0.63 mg/5ml		Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	CONCENTRATE / ORAL		104 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	TABLET, EXTENDED RELEASE / ORAL		290 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	POWDER, FOR SUSPENSION / ORAL		5010 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / DENTAL	0.12 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, EFFERVESCENT / ORAL		4 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	GRANULE, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2754aad5-00ec-4788-9efd-2d0c774804d8			96ef6c88-ce06-4d7a-ab7b-42af64ba3149	2019-12-17	Warnings	Exact identifier spl id: 2754aad5-00ec-4788-9efd-2d0c774804d8 spl set id: 96ef6c88-ce06-4d7a-ab7b-42af64ba3149

Reported adverse events (FAERS/openFDA)#

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