🇺🇸
United States · US · US:68196-033_3c3db64c-3dad-c118-e063-6294a90adc1b
Maximum Strength Mucus Relief
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSAM'S WEST INC
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168196033564 BLISTER PACK in 1 CARTON (68196-033-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A217780
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "495W7451VQ",
"rxcui": "5032",
"inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
"display_name": "GUAIFENESIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"350764de-7801-b24e-e063-6394a90ab3c3": {
"match": "brand_token",
"title": "MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, GUAIFENESIN) TABLET, FILM COATED [RECKITT BENCKISER LLC]",
"spl_version": "2",
"published_date": "2026-05-15"
}
},
"productid": "68196-033_3c3db64c-3dad-c118-e063-6294a90adc1b",
"productndc": "68196-033",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "217780",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Aug 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "Aug 21, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "Maximum Strength Mucus Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217780",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20250820",
"active_numerator_strength": "1200"
}Related drugs
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