FDA.reportPublic FDA data

Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time

Product NDC
63824-218
11-digit product format
638240218
Labeler code
63824
Product ID
63824-218_52d0ff0a-f583-c022-e063-6294a90a259d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
KIT
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-01
NDC exclude flag
No
Listing certified through
2027-12-31
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
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup
1375932Internal RxNorm lookup
2637730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9aca1a68-893c-4770-8a48-d5d678058253Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-04-08Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time
2020-04-08Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time
2020-01-31Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time
2020-01-31Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-218-22Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time1 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-218-22ML - Milliliter63824-2189e31e9aa-fc0b-45d8-bd47-7ba716d0f9f212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-218CHILDRENS DELSYM COUGH PLUS CHEST CONGESTION DM AND DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]5Current NDC, Legacy NDC, 1 package rows20241222_9aca1a68-893c-4770-8a48-d5d678058253.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 70 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC82e68c65-9898-4106-a2f8-e39d124c703e2025-12-22WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHarris Teeter, LLC89fd57d2-fe49-41cb-b02e-9643e526cf472025-12-22WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLWalgreens464f6645-ca33-1722-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLWalgreen Co.47f38e79-c730-21b9-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLWalgreen Co.47522852-005a-2a66-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreens Co,47653657-80b5-482f-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreen Co.47f89d33-6e0a-4bb4-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Strawberry Cough DropMENTHOL 2.7 MGWalgreen Co.4766afa8-fdaf-05e5-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLWalgreen Co.477b9fc3-c3c5-647e-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropMENTHOLWalgreen Co.477cedee-6bd3-2a34-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINEWalgreens Co.47e0f809-0b30-2b23-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLWalgreen835e276a-493e-1038-e053-2a91aa0a7ea22025-12-21WarningsExact identifier
application number: M012
Walgreens Mixed Berry Benz-Dex LozengesBENZOCAINEWalgreene108731f-6b77-225a-e053-2a95a90ac25c2025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLWalmart Stores Inc.318e7acb-0ebb-4518-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWalmart Stores Inc.316968e1-7715-4caa-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Honey Lemon cough dropsMENTHOLWalmart Stores Inc.317bbd33-6087-3af1-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Good Sense Nasal DecongestantPSEUDOEPHEDRINE HCLL. Perrigo Company455b35b4-3969-411b-8036-887615d71e112025-12-21WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLSafeway Inc.4a4f7f82-1b6c-7082-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637730{1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } PackGPCK9aca1a68-893c-4770-8a48-d5d6780582537
26377301 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) PackPSN9aca1a68-893c-4770-8a48-d5d6780582537
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN9aca1a68-893c-4770-8a48-d5d6780582537
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN9aca1a68-893c-4770-8a48-d5d6780582537
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD9aca1a68-893c-4770-8a48-d5d6780582537
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9aca1a68-893c-4770-8a48-d5d6780582537
26377301 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) PackSY9aca1a68-893c-4770-8a48-d5d6780582537
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY9aca1a68-893c-4770-8a48-d5d6780582537
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY9aca1a68-893c-4770-8a48-d5d6780582537
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY9aca1a68-893c-4770-8a48-d5d6780582537
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY9aca1a68-893c-4770-8a48-d5d6780582537
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY9aca1a68-893c-4770-8a48-d5d6780582537
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY9aca1a68-893c-4770-8a48-d5d6780582537
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9aca1a68-893c-4770-8a48-d5d6780582537

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-218-22638240218221 KIT in 1 CARTON (63824-218-22) * 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE1 kit2017-07-010000-00-00NoNoCurrent