FDA.reportPublic FDA data

NDC 76348-804-05 - HEALING TREE CALMING ANTI-ITCH

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
76348-804
Requested NDC
76348-804-05
Package NDCs from labels
76348-804-05, 76348-804-06
Manufacturer
Renu Laboratories, LLC
Effective date
2025-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HEALING TREE CALMING ANTI-ITCH - Renu Laboratories, LLCRenu Laboratories, LLC2025-11-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-05-14HEALING TREE CALMING ANTI-ITCH CREAM
2025-05-14HEALING TREE CALMING ANTI-ITCH CREAM
2025-01-30HEALING TREE CALMING ANTI-ITCH CREAM
2025-01-30HEALING TREE CALMING ANTI-ITCH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-804-05HEALING TREE CALMING ANTI-ITCH59 mL in 1 BOTTLE, PLASTICCREAM593
76348-804-06HEALING TREE CALMING ANTI-ITCH1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-804HEALING TREE CALMING ANTI-ITCH (HYDROCORTISONE) CREAM [RENU LABORATORIES, LLC]2Current NDC, 2 package rows20250515_fc8bcde9-26e8-a35f-e053-6394a90a3300.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 36 of 214 · 4,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
unii: WI4X0X7BPJ
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
Cough and MucusANTIMONIUM TARTARICUM, EUPHRASIA OFFICINALIS, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, PULSATILLA (PRATENSIS), STANNUM METALLICUM, SULPHURNaturalCare5435e0ba-eef9-42a9-8301-aacacd2409b12026-03-23WarningsExact identifier
unii: ZW3Z11D0JV
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
CHESTAL COLD AND COUGHSOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEEDBoiron4d7a3143-ec9d-310b-e063-6394a90ac46e2026-03-20WarningsExact identifier
unii: ZW3Z11D0JV
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
EarBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.82774eed-a906-4a19-86d9-05ea1462bd612026-03-18WarningsExact identifier
unii: ZW3Z11D0JV
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact identifier
application number: M017
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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