FDA.reportPublic FDA data

Walgreens Childrens

Product NDC
0363-7560
11-digit product format
003637560
Labeler code
0363
Product ID
0363-7560_44e1c78e-5a2e-a020-e063-6394a90ab73a
Type
HUMAN OTC DRUG
Nonproprietary name
Nighttime Cough
Dosage form
LIQUID
Route
ORAL
Labeler
WALGREENS CO.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-16
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 15 mg/10mL; mg/10mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Walgreens Childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE15 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a270cbe3-bf0a-44da-9359-00e218eba239Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-7560-042023-01-30C16284748780-1f386c64a-3720-0266-e053-dadaa90a7c1aWalgreens Children’s Night-Time Cough & Chest Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7560-04Walgreens Childrens118 mL in 1 BOTTLELIQUID1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7560WALGREENS CHILDRENS (NIGHTTIME COUGH) LIQUID [WALGREENS CO.]6Current NDC, Legacy NDC, 1 package rows20241115_a270cbe3-bf0a-44da-9359-00e218eba239.zip

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 4 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leader1d73e966-aa4a-40a0-b42a-fda8e500756e2026-03-13WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreensea1b5ec1-3c8e-437d-8e37-f38ab66d9f782026-03-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8dc17b5d-1cf7-44d2-9e78-d2c6952c7d202026-03-11WarningsExact identifier
application number: M010
sleep aidDIPHENHYDRAMINE HCLRite Aid Corporationbdfd7d87-2b54-4c29-ba69-aad0fab682e72026-03-11WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWal-Mart Stores Inc5ef35ab9-b6e8-4c88-a623-35ac9d6bd3592026-03-05WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLWALMART INC. (see also Equate)84c37f4d-60f6-490e-ba8b-47d1257fa6f82026-02-13WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLP & L Development, LLC59c063ad-6ea3-4f1d-a20e-5e5e062a90982026-02-10WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWinCo Foods, LLCf446e56f-c664-4092-8712-aa3f204172f82026-02-02WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLCd805fab3-9dca-497f-bdc6-c8a7b17361092026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd335b09c6-ee5d-ebdf-e063-6294a90abd122026-01-27WarningsExact identifier
application number: M010
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd32033991-a4f0-f767-e063-6394a90a0b062026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Inc90506598-046f-48d3-b8f5-d6ead03338122026-01-27WarningsExact identifier
application number: M010
DORMMY-LONDIPHENHYDRAMINE HYDROCHLORIDEHaendel Farma, S.A. de C.V.562db961-83cb-4b74-9f34-fecee2c1be172026-01-27WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLBetter Living Brands, LLCdec955d3-817d-454f-b146-9a631e908dbc2026-01-27WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.c4bc3efd-8ca8-22fe-e053-2a95a90aed452026-01-26WarningsExact identifier
application number: M010
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYf000d0b5-8ee8-4db0-99fe-aae5ed20c98e2026-01-19WarningsExact identifier
application number: M010
Unisom SleepMinis Nighttime Sleep-AidDIPHENHYDRAMINE HCLChattem, Inc.a9a44c2f-65eb-4a5a-9e72-43652dce57f72026-01-14WarningsExact identifier
application number: M010
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.9105f4f1-7f94-408d-a025-83afb68dc9f02026-01-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC462ca6cd-8eec-09df-e063-6294a90ac8802026-01-13WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSNa270cbe3-bf0a-44da-9359-00e218eba2397
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCDa270cbe3-bf0a-44da-9359-00e218eba2397
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSYa270cbe3-bf0a-44da-9359-00e218eba2397
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSYa270cbe3-bf0a-44da-9359-00e218eba2397

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7560-0400363756004118 mL in 1 BOTTLE (0363-7560-04) 118 ml2019-07-160000-00-00NoNoCurrent