Calmco

Product NDC
73282-2529
11-digit product format
732822529
Labeler code
73282
Product ID
73282-2529_5532e5c5-78d9-1c24-e063-6394a90aee2a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CHEWABLE GEL
Route
ORAL
Labeler
CalmCo LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-26
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
Calmco
Brand name suffix
Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2046528Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5532fd37-cdd6-97ab-e063-6394a90a3c77Available on FDA.report

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 169 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Sinus, Lil Drug StoreACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATELil' Drug Store Products, Inc.1145440e-b37a-6e5e-e063-6294a90ab4a02024-02-13WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCff48b55a-0d32-47d6-941d-d99c7cf52f942024-02-12WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
application number: M012
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINBest Choice (Valu Merchandisers Company)0f2d371d-f890-41e5-ac11-db5559d324662024-02-02WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC4daca846-8511-4303-9e6c-9469f7f260ba2024-02-02WarningsExact identifier
application number: M012
CVS Health COUGH SUPPRESSANT SOFTGELDEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy, Inc.f676dfeb-fba8-419d-8a47-c3880e4100cc2024-02-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC155a7168-b568-41f4-b8a2-214889b4eccf2024-02-02WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLRejoice International Corp.104e1a38-3472-b9e2-e063-6294a90a38cf2024-02-01WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.104f5b07-eed2-566c-e063-6294a90a65052024-02-01WarningsExact identifier
application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRYACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.5962a73e-72e4-493b-94a7-43bc6cf9c82f2024-02-01WarningsExact identifier
application number: M012
good sense allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEL. Perrigo Company2cfa69b4-e33f-442a-a6df-b021b041da142024-02-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCe5ef7b85-feee-44a7-bd0e-ed91352c74342024-01-31WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.17a07d2d-f2da-4e51-9a77-6f0c174987bb2024-01-31WarningsExact identifier
application number: M012
Maximum strength Max Cold and SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.263dae13-5f92-4505-8bcc-e903d05b9a0c2024-01-31WarningsExact identifier
application number: M012
THERAFLU POWERPODS NIGHTTIME SEVERE COLDACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC39f9feef-4bf2-4f10-9fff-22bbb1d8a4712024-01-30WarningsExact identifier
application number: M012
Theraflu Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCc0689223-5c90-4dbc-bbfa-f94e267504c32024-01-28WarningsExact identifier
application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCa4c56ca0-7785-404b-996d-137cc135f2702024-01-28WarningsExact identifier
application number: M012
THERAFLU NIGHTTIME SEVERE COLD AND COUGHACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC5f7f6f70-0f36-4541-89f2-d953259cdb1e2024-01-28WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73282-2529-17328225290120 CHEWABLE GEL in 1 BOTTLE, PLASTIC (73282-2529-1) 20 chewable gel2026-06-26NoNoCurrent